Outright purchase, installation, programming, servicing and maintenance of a building management system and environmental monitoring system for a 5-year period, including calibration and training for staff.

2.1 Based on the Bids submitted and the outcome of the evaluation process according to the set evaluation

criteria, NHLS intends to select a preferred bidder with the view of concluding a service level agreement

(SLA) with such successful bidder. The Bid shall be evaluated in terms of the Preferential Procurement

Policy Framework Act (PPPFA)

2.2 Queries

2.2.1 Should it be necessary for a bidder to obtain clarity on any matter arising from or referred to in this RFB

document, please refer queries, in writing, and to the contact person email address number listed below

on or before 15 September 2026 Under no circumstances may any other employee within NHLS be

approached for any information. Any such action might result in a disqualification of a response submitted

in competition to the RFB. NHLS reserves the right to place responses to such queries on the website.

Telephone 011 555 0595

South African Vaccine producers are currently investing in an Electronic Building Management

System/Environmental Monitoring System (EMS) to continuously monitor and record critical

environmental parameters—particle counts, temperature, relative humidity, differential pressure,

and—within classified areas of the SAVP pharmaceutical manufacturing facility. The system must

comply with EU GMP Annex 1 (2023), 21 CFR Part 11, EU GMP Part 11, GAMP (Good Automated

Manufacturing Practices) 5, and other applicable regulatory guidelines.

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4. Mandatory requirements

If a bidder does not comply fully with each of the mandatory requirements, it Shall be regarded as mandatory

non-performance/non-compliance and the bid Shall be disqualified. No “unanswered” questions will be

allowed. If a response to a question has been indicated as comply but not elaborated upon or substantiated it

shall be regarded as mandatory non- performance/non-compliance and the bid shall be disqualified.

Bidders shall provide full and accurate answers to the mandatory questions posed in this document, and, where

required, explicitly state either “Comply/Accept (with a “Yes”)” or “Do not comply/do not accept (with a “No”)”

regarding compliance to the requirements. Bidders must substantiate their responses to all mandatory

questions. PLEASE NOTE: If the response does not substantiate any of the points or requirements in the body of

the tender, it will be deemed to not comply, even if the ‘Comply’ field has been marked. Please note: All

documentation to substantiate the mandatory requirements has to be supplied.

The bidder who fails to comply with the Mandatory Requirements will be disqualified.

No. Description Comply Do Not Comply

1. Project plan

a. Risk assessment and needs analysis to cover all essential areas of the

production facility, ensuring compliance with current South African and

NHLS safety requirements.

b. Integration of EMS into existing infrastructure including BMS, LMS and Fire

alarm system.

c. Demonstration of data collection, fidelity and retrieval systems including

audit trails, password security and storage facility

d. Demonstration of alarm systems which should include audible and visual

alarms and alerts which are fed through to HMI sms system, email

notification.

e. Validation and verification plan for QT, FAT etc.

f. Training plan.

Substantiation: The bidder must provide a detailed project plan detailing the above items.

2. Bidder must provide 2 contactable reference letters indicating the scope of work

and the facility from 2 pharmaceutical grade facilities.

Substantiation: The bidder must attach two letters on a client’s letterhead.

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.

No. Description Comply Do Not Comply

3. The EMS must cover the following:

a) Clean rooms and controlled environments (Grade A, B, C, D).

b) HVAC systems interfacing (for pressure, temperature, humidity data).

c) Cleanroom particle monitoring systems.

d) Water system total organic carbon and conductivity monitoring.

e) Viable microbial air sampling systems (need to have a separate particle counter).

f) 12 Cold storage, 2 Incubators, and 1 Ultra-low freezers.

g) Data management and reporting functions for QA, Production, and Engineering

departments. (Demonstration by means of brochure).

h) Fire alarm system.

Substantiation: Bidder must submit a commitment letter covering a-h.

4. Bidder must provide two reference letters on Client’s letterhead with 2 contactable Comply Do Not comply

references detailing that they completed similar work.

Substantiation: The bidder must attach two letters on a client’s letterhead.

5. Supply, delivery and installation of Environmental Monitoring System (EMS) that Comply Do Not Comply

meets the following specifications:

Environmental Monitoring System (EMS) to fully meet the below specifications:

a) Scope This URS applies to the procurement, installation, qualification, and

operation of an EMS that covers:

• Clean rooms and controlled environments (Grade A, B, C, D).

• HVAC systems interfacing (for pressure, temperature, humidity data).

• Cleanroom particle monitoring systems.

• Water system total organic carbon and conductivity monitoring.

• Viable microbial air sampling systems (need to have a separate particle

counter).

• Data management and reporting functions for QA, Production, and

Engineering departments.

b) System Overview

• The EMS shall provide real-time, continuous monitoring of environmental

parameters (pressure, temperature, humidity, Total Organic Carbon,

conductivity, particles etc), generate alerts and alarms (Audible alarm

attached to the equipment, SMS, Email) for any excursions, and store all

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Closing date: 30 September 2026 at 11:00 AM. Compulsory briefing session: 11 September 2026 at 11:00 AM at SAVP Library, 1 Modderfontein Road, Sandringham, Johannesburg. Late coming will not be accepted. All questions must be emailed to [email protected] on or before 15 September 2026. Public tender opening: 30 September 2026 at 11:30 AM at Main Conference Boardroom, NHLS, 1 Modderfontein Road, Sandringham.

Compulsory briefing session will be held on 11 September 2026 at 11:00 AM at SAVP Library, 1 Modderfontein Road, Sandringham, Johannesburg. Late coming will not be accepted. All questions must be sent via email to [email protected] on or before 15 September 2026.

Bidding procedure enquiries: Phillip Serage, telephone 011 555 0595, email [email protected]. Technical enquiries: Simon Machaba, telephone 082 328 2119, email [email protected]. Queries must be directed only to these contacts; approaching other NHLS employees may lead to disqualification.

Bids must be submitted in two sealed envelopes inside an outer envelope. The first envelope, marked "BID / Proposal Section", holds all documents except pricing. The second, marked "PRICING Section", holds the pricing schedule, price declaration and supporting pricing documentation. Submit one original, one hard copy and one electronic copy on a USB flash drive in PDF format. The original must be signed in black ink by an authorised representative, and every page initialled. Bids must be deposited in the bid box at NHLS Main Reception, 1 Modderfontein Road, Sandringham, Johannesburg, before 11:00 on 30 September 2026. Bids too large for the box must be handed in at reception during office hours (08:00–16:30) or before 11:00 on closing date. Bids sent by post or courier must reach the office at least 36 hours before closing. Late bids will not be accepted. Telephonic, faxed, emailed or oral bids are not accepted. Bids must be on the official forms; any alteration to wording will lead to disqualification. Returnable forms include SBD 1 (Invitation to Bid), SBD 4 (Bidder's Disclosure), SBD 6.1 (Preference Points Claim), SBD 7 (Contract Form), and proof of authority to sign (e.g. company resolution). Failure to sign mandatory documents or to price according to the costing template will result in disqualification.

Mandatory returnable documents include: proof of attendance at compulsory briefing session and site visit; accepted NHLS Special Conditions of Contract; fully completed and signed Bidder's Disclosure SBD 4. Essential returnable documents include: valid Tax Clearance Certificate or Tax Compliance Status letter with PIN; B-BBEE certificate or sworn affidavit; audited financial statements not older than two years.

Evaluation is based on the 80/20 PPPFA principle: price 80 points, specific goals 20 points, total 100 points. The process has four stages: Stage 1 Administrative Compliance verification, Stage 2 Technical Mandatory requirement evaluation, Stage 3 Technical Functionality requirement evaluation, Stage 4 Price/Specific Goals evaluation. Bidders must pass each stage to proceed. The BID/Proposal envelope is opened first; the PRICING envelope is only opened for bidders who meet the minimum predefined functionality threshold. The Cross Functional Evaluation Team (CFET) evaluates technical and functional aspects. Bidders that score the minimum threshold are recommended to the Bid Adjudication Committee (BAC), and the contract is awarded to the bidder with the highest total points (Merit 1).

The system must be an Electronic Building Management System/Environmental Monitoring System (EMS) for the SAVP pharmaceutical manufacturing facility, to continuously monitor and record critical environmental parameters including particle counts, temperature, relative humidity, differential pressure, total organic carbon, and conductivity. It must comply with EU GMP Annex 1 (2023), 21 CFR Part 11, EU GMP Part 11, GAMP 5, and other applicable regulatory guidelines. The EMS must cover: clean rooms and controlled environments (Grade A, B, C, D); HVAC systems interfacing for pressure, temperature, humidity data; cleanroom particle monitoring systems; water system total organic carbon and conductivity monitoring; viable microbial air sampling systems (with a separate particle counter); 12 cold storage units, 2 incubators, and 1 ultra-low freezer; data management and reporting functions for QA, Production, and Engineering departments; and fire alarm system integration. The system must provide real-time continuous monitoring, generate alerts and alarms (audible, SMS, email) for excursions, and store all data. Mandatory requirements include: a project plan covering risk assessment, integration with existing BMS/LMS/fire alarm, data collection and retrieval with audit trails, alarm systems, validation and verification plan (DQ, FAT, IQ, OQ, PQ), and training plan; two contactable reference letters from pharmaceutical grade facilities; a commitment letter covering the EMS scope; and supply, delivery, installation, qualification, and operation of the EMS. The system must include UPS and power backup for at least 2 hours. At least 12 months' warranty is required. The supplier must provide spares, preventative and corrective maintenance, and standby service after hours, weekends and holidays.

Bidders must provide full and accurate answers to all mandatory questions, explicitly indicating 'Comply/Accept' or 'Do not comply/Do not accept'. Responses must be substantiated; failure to substantiate will be deemed non-compliance and may lead to disqualification. Bidders must promote growth and development of SMMEs and will be assessed on their efforts.

7.1 Identify key personnel, by employer (include subcontractor(s) and provide contact information.

8. Reasons for Disqualification

8.1 NHLS reserves the right to disqualify any bidder which does any one or more of the following, and such

disqualification may take place without prior notice to the offending bidder, however the bidder shall be

notified in writing of such disqualification:

8.1.1 bidders who submitted did not sign the mandatory documents;

8.1.2 bidders who submitted information that is fraudulent, factually untrue or inaccurate, for example

memberships that do not exist, B-BBEE credentials, experience, etc.;

8.1.3 bidders who received information not available to other vendors through fraudulent means;

8.1.4 bidders who do not comply with mandatory requirements as stipulated in this RFB; and

8.1.5 bidders who fail to price according to the costing template provided;

9. Bid Preparation

9.1 All additions to the proposal documents i.e. annexes, supporting documentation pamphlets, photographs,

technical specifications and other support documentation covering the goods offered etc. shall be neatly

bound as part of the schedule concerned.

9.2 All responses regarding questions posed in the annex attached herewith shall be answered in accordance

with the prescribed RFB Response Format.

9.3 Telephonic, faxed, e-mailed or oral tenders shall not be accepted.

10. Oral presentations and Briefing Sessions

10.1 Bidders who submit Bids in response to this RFB may be required to give an oral presentation, which may

include, but is not limited to, an equipment/service demonstration of their proposal to NHLS. This provides

an opportunity for the vendor to clarify or elaborate on the proposal. This is a fact finding and explanation

session only and does not include negotiation. NHLS shall schedule the time and location of these

presentations. Oral presentations are an option of NHLS and may or may not be conducted and must not

be construed as being successful in or awarded the tender.

11. General Conditions of Bid and Conditions of Contract

11.1 Bidders shall provide full and accurate answers to all (including mandatory) questions posed in this

document and are required to explicitly indicate either "Comply/Accept (with a )" or "Do not comply/Do

not accept (with an X)" regarding compliance with the requirements. Where a condition is not applicable,

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an “N/A” option is provided, and bidders must clearly indicate this by marking with an “X”. Where

necessary, the bidder shall substantiate their response to a specific question.

NOTE: It is mandatory for bidders to complete or answer this part fully (11.2 to 11.34); otherwise, their

bid shall be treated as incomplete and shall be disqualified. Refer to paragraph 8 of this document

(reasons for disqualification).

11.2

Accept Do not Accept This bid is subject to the General Conditions of Contract stipulated in this document.

11.3

The laws of the Republic of South Africa shall govern this RFB, and the Bidders hereby Accept Do not Accept

accept that the courts of the Republic of South Africa shall have the jurisdiction.

11.4

NHLS shall not be liable for any costs incurred by the bidder in the preparation of Accept Do not Accept

response to this RFB. The preparation of response shall be made without obligation

to acquire any of the items included in any bidder’s proposal or to select any proposal,

or to discuss the reasons why such vendor’s or any other proposal was accepted or

rejected.

11.5

NHLS Procurement Services may request written clarification regarding any aspect of Accept Do not Accept

this proposal. The bidders must supply the requested information in writing within the

specified time frames after the request has been made, otherwise the proposal shall

be disqualified.

11.6

Do not N/A

In the case of Consortium, Joint Venture or subcontractors, bidders are required to Accept

Accept

provide copies of signed agreements stipulating the work split and Rand value.

11.7

Do not N/A

In the case of Consortium, Joint Venture or subcontractors, all bidders are required to Accept Accept

provide mandatory documents as stipulated in schedule 1 of the Response format.

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11.8

NHLS reserves the right to; cancel or reject any proposal and not to award the Accept Do not Accept

proposal to the lowest bidder or award parts of the proposal to different bidders, or

not to award the proposal at all.

11.9

Where applicable, bidders who are distributors, resellers and installers of network Accept N/A Do not Accept

equipment are required to submit back-to-back agreements and service level

agreements with their principals.

11.10

By submitting a proposal in response to this RFB, the bidders accept the evaluation Accept Do not Accept

criteria as it stands.

11.11

Where applicable, NHLS reserves the right to conduct benchmarks on Accept Do not Accept

product/services offered during and after the evaluation.

11.12

NHLS reserves the right to conduct a pre-award survey during the source selection Accept Do not Accept

process to evaluate contractors' capabilities to meet the requirements specified in

the RFB and supporting documents.

11.13

Where the bid calls for commercially available solutions, bidders who offer provide Accept Do not Accept

future based solutions will be disqualified.

11.14

The bidder should not qualify the proposal with own conditions. Accept Do not Accept

Caution: If the bidder does not specifically withdraw its own conditions of proposal

when called upon to do so, the proposal response shall be declared invalid.

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11.15

Accept Do not Accept

Should the bidder withdraw the proposal before the proposal validity period expires,

NHLS reserves the right to recover any additional expense incurred by NHLS having to

accept any less favourable proposal or the additional expenditure incurred by NHLS in

the preparation of a new RFB and by the subsequent acceptance of any less favourable

proposal.

11.16

Accept Do not Accept

Delivery of and acceptance of correspondence between NHLS and the bidder sent by

prepaid registered post (by air mail if appropriate) in a correctly addressed envelope

to either party’s postal address or address for service of legal documents shall be

deemed to have been received and accepted after (2) two days from the date of

postage to the South African Post Office Ltd.

11.17

Accept Do not Accept

Should the parties at any time before and/or after the award of the proposal and prior

to, and-or after conclusion of the contract fail to agree on any significant product

price or service price adjustments, change in technical specification, change in

services, etc. NHLS shall be entitled within 14 (fourteen) days of such failure to agree,

to recall the letter of award and cancel the proposal by giving the bidder not less than

90 (ninety) days written notice of such cancellation, in which event all fees on which

the parties failed to agree increases or decreases shall, for the duration of such notice

period, remain fixed on those fee/price applicable prior to the negotiations.

Such cancellation shall mean that NHLS reserves the right to award the same proposal

to next best bidders as it deems fit.

11.18

Do not N/A

In the case of a consortium or JV, each of the authorised enterprise’s members and/or Accept

Accept

partners of the different enterprises must co-sign this document.

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11.19

Any amendment or change of any nature made to this RFB shall only be of force and Accept Do not Accept

effect if it is in writing, and an Amendment to the RFB will be issued. Bidders will be

required to utilise the latest Amendment in preparation of their bid response.

11.20

Failure or neglect by either party to (at any time) enforce any of the provisions of this Accept Do not Accept

proposal shall not, in any manner, be construed to be a waiver of any of that party’s

right in that regard and in terms of this proposal. Such failure or neglect shall not, in

any manner, affect the continued, unaltered validity of this proposal, or prejudice the

right of that party to institute subsequent action.

11.21

Bidders who make use of subcontractors. Accept Do not Accept

The proposal shall however be awarded to the Vendor as a primary contractor who

shall be responsible for the management of the awarded proposal. No separate

contract shall be entered into between NHLS and/or its client and any such

subcontractors. Copies of the signed agreements between the relevant parties must

be attached to the proposal responses.

11.22

All services supplied in accordance with this proposal must be certified to all legal Accept Do not Accept

requirements as per the South African law.

11.23

No interest shall be payable on accounts due to the successful vendor in an event of a Accept Do not Accept

dispute arising on any stipulation in the contract.

11.24

Evaluation of Bids shall be performed by a CFET established by NHLS. Accept Do not Accept

Bids shall be evaluated on the basis of conformance to the required specifications as

outlined in the RFB. Points shall be allocated to each bidder, on the basis that the

maximum number of points that may be scored for price is 80/90, and the maximum

number of preference points that may be claimed for Specific Goals (according to the

PPPFA) is 20/10.

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11.25

Prior to the award of any tender or contract the NHLS will check the Prohibition status Accept Do not Accept

of recommended suppliers/ service providers on the Treasury website

([email protected]) as well as the Treasury Register for Tender Defaulters

(www.treasury.gov.za)

11.26

Accept Do not Accept

The NHLS will act against the bidder or person awarded the contract upon detecting

that the B-BBEE status level of contribution has been claimed or obtained on a

fraudulent basis or any of the contract conditions have not been fulfilled.

11.27

The NHLS may, in addition to any other remedy that it may have against the bidder Accept Do not Accept

or person:

• Disqualify the bidder or person from the bidding process;

• Recover all costs, losses or damages it has incurred;

• or suffered as a result of that person’s conduct;

• Cancel the contract and claim any damages which it;

• has suffered as a result of having to make less;

• favourable arrangements due to such cancellation;

• Restrict the bidder or contractor, its shareholders;

• and directors, or only the shareholders and directors;

• who acted on a fraudulent basis, from obtaining business;

• from any organ of state for a period not exceeding 10;

• years, after applying the audi alteram partem (hear the other side) rule;

• Forward the matter for Blacklisting by Treasury; and

• Forward the matter for criminal prosecution

11.28

If the successful bidder disregards contractual specifications, this action may result in Accept Do not Accept

the termination of the contract.

11.29

The bidders’ response to this Tender, or parts of the response, shall be included as a Accept Do not Accept

whole or by reference in the final contract.

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11.30

NHLS has discretion to extend the validity period should the evaluation of this bid not Accept Do not Accept

be completed within the stipulated validity period.

11.31

Upon receipt of the request to extend the validity period of the bid, the bidder must Accept Do not Accept

respond within the required time frames and in writing on whether or not he agrees

to hold his original bid response valid under the same terms and conditions for a

further period.

11.32

Should the bidder change any wording or phrase in this document, the bid shall be Accept Do not Accept

deemed unresponsive and may lead to the disqualification of the bid response.

11.33

11.34

Accept Do not Accept

No alternative tender offers will be considered.

12. Nhls special conditions of contract.

12.1 Bidders shall provide full and accurate answers to all (including mandatory) questions posed in this

document and are required to explicitly indicate either "Comply/Accept (with a )" or "Do not comply/Do

not accept (with an X)" regarding compliance with the requirements. Where necessary, the bidder shall

substantiate their response to a specific question.

12.2 NOTE: It is mandatory for bidders to complete or answer this part fully (12.2.1 to 12.2.8); otherwise, their

bid shall be treated as incomplete and shall be disqualified. Refer to paragraph 8 of this document (reasons

for disqualification).

(NOTE: Failure to address the items in the scope of works WILL lead to disqualification).

No. Description Accept Do Not Accept

12.2.1 The bidder must provide the Qualification documentation for the automated

Building Management System/Environmental Monitoring System (EMS) and its

controls with each milestone of the project:

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No. Description Accept Do Not Accept

• Design Qualification (DQ)

• Factory Acceptance Test (FAT)

• Installation Qualification (IQ)

• Operations Qualification (OQ)

• Performance Qualification (PQ)

12.2.2. At least 12 months’ warranty documentation.

12.2.3. Bidder must accept drafting and submitting a Risk assessment for the environmental

monitoring system.

Risk assessment should detail the following:

a) Risk assessments should be performed to establish the comprehensive

environmental monitoring programme, i.e. sampling locations, frequency of

monitoring and monitoring methods.

b) These risk assessments should be conducted based on detailed knowledge

of the process inputs and final product, the facility, equipment, the

criticality of specific processes and steps, the operations involved, routine

monitoring data, monitoring data obtained during qualification.

12.2.4. UPS and Power backup for at least 2 hours to ensure data capture during power

failure.

12.2.5. a) Training and Support

Supplier to provide comprehensive training for:

• System operation

• Administration and configuration

• Maintenance and calibration

• Data review and reporting

• Ongoing technical support and periodic system health checks.

12.2.6. Five years’ Service and Maintenance of the Environmental monitoring system

(Ems).

This phase focuses on servicing and maintenance of the installed

environmental monitoring system for a period of five (5) years. The work

includes, but is not limited to:

• Develop, implement and maintain an effective program of the equipment

and outage maintenance work.

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No. Description Accept Do Not Accept

• Performs equipment inspections to ensure that the equipment is safely

maintained and operable; performs related testing and repair as needed.

• The Provision of Spares for maintenance (Preventative & corrective and

remedial)

• Provide qualified and competent personnel to perform preventative

maintenance (PM), corrective maintenance (CM).

• Provide a standby service after hours with weekends and holidays included.

12.2.7. The supplier/installer must comply with the Occupational Health and Safety Act and

relevant regulations.

12.2.8. A valid Electrical Certificate of Compliance (CoC), issued by a registered electrician,

must be provided for all electrical work related to the EMS installation. The CoC must

be submitted as part of the handover documentation. Failure to provide the CoC will

result in non-acceptance of the installation. Failure to provide the CoC will result in

non-acceptance of the installation.

13. Evaluation Criteria and Methodology

13.1 Evaluation of tenders and selection of contractors’/service providers

The NHLS is a Schedule 3A Government Institution subjected to the Public Finance Management Act

(PFMA), the Public Preferential Framework Act (PPPFA) and Treasury Regulations/ Instructions. Bidders

must assist the NHLS to eliminate corruption and fraud by completing and submitting form SBD4.

13.1.1. A public bid opening will be conducted at the bid closing date and time for all bids received in the bid/tender

box. The bidder’s name will be announced to the attendees of the public opening. The same information

will be published on the NHLS website. Financial offers or prices will not be disclosed or read out during

the public opening. The public disclosure of pricing will be only of the awarded bidder at the conclusion of

the procurement process.

13.1.2 Next steps of evaluation is administrative compliance verification and the “technical” or so called

“functional” evaluation which is purely based on NHLS specifications (Annexure 2) and Scope of Work. NHLS

end-user department (who requested the bid), Procurement Services, Finance and subject specialists are

part of the Cross Functional Evaluation Team (CFET) meeting which is chaired by Quality Assurance (QA).

All the members of the CFET must complete Declaration of Interest forms and must recuse themselves in

case of any conflict of interest.

13.1.3 The final stage of evaluation is done after the CFET has reached their verdict and is done by NHLS

Procurement Services and separately from the CFET meeting. Points for Specific Goals (commercial

evaluation) is being added in order to get the final order of merit for the bidders being evaluated.

13.1.4 Bidders that score the minimum threshold are recommended and submitted to the NHLS Bid

Adjudication Committee (BAC) for adjudication and the bid MUST be awarded to the bidder who scored

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the highest points (Merit 1) during the CFET and Commercial evaluation (Specific Goals). All the

members of the CFET must complete Declaration of Interest forms and must recuse themselves in case

of any conflict of interest. Should the BAC decide on a bidder other than Merit 1, this decision must be

motivated as a Deviation from NHLS Policy & procedure and Treasury must be advised accordingly.

13.1.5 The CEO of the NHLS must finally approve the recommendation by the Bid Adjudication Committee

(BAC), in his/her capacity as the Accounting Officer.

13.1.6 Details of the successful bidder to be advertised in the National Treasury e-tender portal.

13.1.7 Suppliers must accept the Terms & Conditions of our contract(s) which will result from the RFB

document”. RFB conditions and pricing shall be fixed and firm from RFB closing date to the end of

contract.

13.2 Bid evaluation stages

The bid evaluation process consists of several stages that are applicable according to the nature of the

bid as defined below:

Stage 1: Administrative Compliance verification

Stage 2: Technical Mandatory requirement evaluation

Stage 3: Technical Functionality requirement evaluation

Stage 4: Price / Specific Goals evaluation

NOTE: The bidder must qualify for each stage to be eligible to proceed to the next stage of the

evaluation.

13.3 Administrative compliance requirements

Administrative compliance/responsiveness will be tested based on returnable documents submitted

and signatures on the Bid documents.

At this stage, it must be determined what documents are required to be returned by Bidders.

Returnable documents are categorised as follows:

a) Mandatory Returnable Documents

(NOTE: Failure to provide the below listed documents WILL lead to disqualification).

Comply Do Not Comply

1. Proof of Attendance of Compulsory Briefing session and site visit.

Substantiation: The bidder is to indicate whether they have attended the Compulsory Briefing session and site visit.

2. The Service Providers to have to agree with NHLS General Conditions of Bid and Comply Do Not Comply

conditions of Contract.

Substantiation: The bidder must submit and attach to the bid response the signed and accepted NHLS General contract

terms and conditions.

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3. The Service Providers have to agree with NHLS Special Conditions of Contract. Comply Do Not Comply

Substantiation: The bidder must submit and attach to the bid response the accepted NHLS Special Conditions of

Contract.

4. Fully completed and signed Bidder’s Disclosure SBD 4. Comply Do Not Comply

Substantiation: The bidder must submit and attach to the bid response the signed Bidder’s Disclosure SBD 4.

b) Essential Returnable Documents

(NOTE: Failure to provide the below listed documents MAY lead to disqualification).

Submission of original valid Tax Clearance Certificate or a Tax Compliance Status Comply Do Not Comply

1. letter (with pin) issued by the South African Revenue Services.

Substantiation: The bidder must submit and attach to the bid response a copy of a valid certificate.

Preferential Procurement Claim form and copy of the B-BBEE Verification Comply Do Not Comply

Certificate(s) issued by an authorised body or person, or a sworn affidavit

prescribed by the B-BBEE Codes of Good Practice.

Substantiation: The bidder must submit and attach to the bid response a valid BBBEE Certificate/Affidavit.

Comply Do Not Comply

Audited financial statements not older than two (2) years.

Substantiation: The bidder must submit and attach to the bid response two years financial statements.

Comply Do Not Comply

Proof of Central Supplier Database (CSD) Registration.

Substantiation: The bidder must submit a CSD Report with the bid response.

• Compliant with EU GMP Annex 1 (2023) requirements for environmental monitoring.

• Compliant with 21 CFR Part 11 and EU GMP Annex 11 for electronic data integrity.

Substantiation: The bidder must submit a commitment letter that the supplied system will be Compliant with

EU GMP Annex 1 (2023) requirements for environmental monitoring and 21 CFR Part 11 and EU GMP Annex 11

for electronic data integrity.

The bidder/manufacturer must provide a Letter of Good Standing from the Comply Do Not Comply

Department of Employment and Labour (COIDA).

6. Substantiation: Bidder/Manufacturer must submit and attach a Letter of Good Standing from the Department

of

Labour (COIDA).

13.4 The evaluation of the Bids shall be based on the 80/20 PPPFA principle and the points for evaluation

criteria are as follows:

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Price points 80

Specific Goals 20

Total 100 points

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ANNEXURE A: Technical Specification

1 special instructions to vendors

1.1 Should a Bidder have reasons to believe that the Technical Specification is not open and/or is written for

a particular brand or product; the Bidder shall notify Procurement Services within ten (10) days after

publication of the bid.

1.2 Bidders shall provide full and accurate answers to the mandatory questions posed in this document, and,

where required explicitly state either “Comply/Not Comply” regarding compliance with the requirements.

Bidders must substantiate their response to all questions, including full details on how their

proposal/solution will address specific functional requirements. All documents as indicated must be

supplied as part of the submission.

1.3 Bidders are encouraged to promote the growth and development of SMME’s and will be assessed on their

efforts in this regard during the evaluation of this Tender.

2 acronyms and abbreviations

Term Definition

EBS Oracle e-Business Suite

DR Disaster Recovery

DB Database

NHLS National Health Laboratory Service

PMO Project Management Office

SLA Service Level Agreement

8.1 NHLS reserves the right to disqualify any bidder which does any one or more of the following, and such

disqualification may take place without prior notice to the offending bidder, however the bidder shall be

notified in writing of such disqualification:

8.1.1 bidders who submitted did not sign the mandatory documents;

8.1.2 bidders who submitted information that is fraudulent, factually untrue or inaccurate, for example

memberships that do not exist, B-BBEE credentials, experience, etc.;

8.1.3 bidders who received information not available to other vendors through fraudulent means;

8.1.4 bidders who do not comply with mandatory requirements as stipulated in this RFB; and

8.1.5 bidders who fail to price according to the costing template provided;

• Performs equipment inspections to ensure that the equipment is safely

maintained and operable; performs related testing and repair as needed.

• The Provision of Spares for maintenance (Preventative & corrective and

remedial)

• Provide qualified and competent personnel to perform preventative

maintenance (PM), corrective maintenance (CM).

• Provide a standby service after hours with weekends and holidays included.

12.2.7. The supplier/installer must comply with the Occupational Health and Safety Act and

relevant regulations.

12.2.8. A valid Electrical Certificate of Compliance (CoC), issued by a registered electrician,

must be provided for all electrical work related to the EMS installation. The CoC must

be submitted as part of the handover documentation. Failure to provide the CoC will

result in non-acceptance of the installation. Failure to provide the CoC will result in

non-acceptance of the installation.

13.1 Evaluation of tenders and selection of contractors’/service providers

The NHLS is a Schedule 3A Government Institution subjected to the Public Finance Management Act

(PFMA), the Public Preferential Framework Act (PPPFA) and Treasury Regulations/ Instructions. Bidders

must assist the NHLS to eliminate corruption and fraud by completing and submitting form SBD4.

13.1.1. A public bid opening will be conducted at the bid closing date and time for all bids received in the bid/tender

box. The bidder’s name will be announced to the attendees of the public opening. The same information

will be published on the NHLS website. Financial offers or prices will not be disclosed or read out during

the public opening. The public disclosure of pricing will be only of the awarded bidder at the conclusion of

the procurement process.

13.1.2 Next steps of evaluation is administrative compliance verification and the “technical” or so called

“functional” evaluation which is purely based on NHLS specifications (Annexure 2) and Scope of Work. NHLS

end-user department (who requested the bid), Procurement Services, Finance and subject specialists are

part of the Cross Functional Evaluation Team (CFET) meeting which is chaired by Quality Assurance (QA).

a) Clean rooms and controlled environments (Grade A, B, C, D).

b) HVAC systems interfacing (for pressure, temperature, humidity data).

c) Cleanroom particle monitoring systems.

d) Water system total organic carbon and conductivity monitoring.

e) Viable microbial air sampling systems (need to have a separate particle counter).

f) 12 Cold storage, 2 Incubators, and 1 Ultra-low freezers.

g) Data management and reporting functions for QA, Production, and Engineering

departments. (Demonstration by means of brochure).

h) Fire alarm system.

Substantiation: Bidder must submit a commitment letter covering a-h.

4. Bidder must provide two reference letters on Client’s letterhead with 2 contactable Comply Do Not comply

references detailing that they completed similar work.

Substantiation: The bidder must attach two letters on a client’s letterhead.

5. Supply, delivery and installation of Environmental Monitoring System (EMS) that Comply Do Not Comply

meets the following specifications:

Environmental Monitoring System (EMS) to fully meet the below specifications:

a) Scope This URS applies to the procurement, installation, qualification, and

operation of an EMS that covers:

• Clean rooms and controlled environments (Grade A, B, C, D).

• HVAC systems interfacing (for pressure, temperature, humidity data).

• Cleanroom particle monitoring systems.

• Water system total organic carbon and conductivity monitoring.

• Viable microbial air sampling systems (need to have a separate particle

counter).

• Data management and reporting functions for QA, Production, and

bidder and each and every page of the proposal shall contain the initials of same signatories.

5.12.2 The bidders are required to submit their bids/tenders in TWO envelopes:

(a) the first envelope to be clearly marked “BID / Proposal Section”. The first envelope holds all

documents, excluding the price schedule, price declaration and detailed supporting pricing

documentation; and

(b) the second envelope to be clearly marked “PRICING Section”. The second envelope holds the

pricing schedule, price declaration and the detailed supporting pricing documentation.

Pricing must be submitted in a separate envelope marked "PRICING Section" with the RFB number, description and bidder's name. The pricing schedule (Annexure B) must be completed according to the costing template provided; failure to price according to the template leads to disqualification. The bid validity period is 180 days from the closing date. Bidders must provide a solvency statement signed by a qualified independent auditor confirming the company's financial position is sound and that it can mobilise financial resources to deliver the project.

Bidders must be registered on the Central Supplier Database (CSD) and provide a CSD registration report. A valid Tax Clearance Certificate or Tax Compliance Status PIN from SARS must be submitted; for consortia, joint ventures or subcontractors, each party must submit a separate TCS certificate/PIN/CSD number. B-BBEE status level verification certificate or sworn affidavit (for EMEs and QSEs) must be submitted to qualify for preference points. Bids from persons in the service of the state, or companies with directors who are, will not be considered. Bidders must complete and sign SBD 4 (Bidder's Disclosure) and SBD 6.1 (Preference Points Claim). The successful bidder must sign SBD 7 (Contract Form). Proof of authority to sign (e.g. company resolution) must be submitted. Employees and subcontractors may be required to hold security clearances determined by the State Security Agency (SSA) or NHLS, at the bidder's cost. Bidders must warrant coverage under the Compensation for Occupational Injuries and Diseases Act and may be required to provide proof of good standing with the Compensation Fund.

Contract (gcc) and, if applicable, any other special conditions of contract.

The following particulars must be furnished (failure to do so shall result in your bid being

Disqualified)

Sbd1

3.1 National Health Laboratory Services [hereinafter referred to as NHLS] is a public health laboratory service

with laboratories across South Africa. Its activities comprise diagnostic laboratory services, research,

teaching and training, and production of sera for anti-snake venom, reagents and media.

3.2 NHLS was established in 2001 by an Act of Parliament to provide diagnostic pathology laboratory services

to the National and Provincial Health Department.

3.3 “Acceptable Bid” - means any bid, which, in all respects, complies with the specifications and conditions

of the RFB as set out in this document.

3.4 “B-BBEE” – means broad bases black economic empowerment as defined in section 1 of the Broad-Based

areas of ownership (shareholding), skills transfer, employment equity and procurement practices

(SMME Development) etc.

5.4.2 NHLS shall apply the principles of the Preferential Procurement Policy Framework Act, (Act No. ) to this proposal.

5.4.3 Bidders shall complete the preference certificate attached to this proposal. In the case of a consortium

and sub-contractors, the preference certificate must be completed for each legal entity.

5.5 National Industrial Participation Programme

5.5.1 The Industrial Participation policy, which was endorsed by Cabinet on 30 April 1997, is applicable to

contracts that have an imported content. The NIP is obligatory and therefore must be complied with.

Bidders are required to sign and submit the Standard Bidding Document (SBD5).

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5.6 Language

5.6.1 Bids shall be submitted in English.

5.7 Gender

5.7.1 Any word implying any gender shall be interpreted to imply all other genders.

5.8 Headings

5.8.1 Headings are incorporated into this proposal and submitted in response thereto, for ease of reference

only and shall not form part thereof for any purpose of interpretation or for any other purpose.

5.9 Security clearances

5.9.1 Employees and subcontractors of the successful bidder may be required to be in possession of valid

security clearances to the level determined by the State Security Agency (SSA) and/or NHLS

commensurate with the nature of the project activities they are involved in. The cost of obtaining

suitable clearances is for the account of the bidders. The bidders shall supply and maintain a list of

personnel involved on the project indicating their clearance status.

5.9.1 Employees and subcontractors of the successful bidder will be required to sign a non-disclosure

agreement.

5.10 Occupational Injuries and Diseases Act

5.10.1 The Bidder warrants that all its employees (including the employees of any sub-contractor that may be

appointed) are covered in terms of the Compensation for Occupational Injuries and Diseases Act and that the cover shall remain in force for the duration of the adjudication of this bid and/ or

subsequent agreement. NHLS reserves the right to request the Bidder to submit documentary proof of

the Bidder’s registration and “good standing” with the Compensation Fund, or similar proof acceptable

to NHLS.

5.11 Formal contract

5.11.1 This RFB, all the appended documentation and the proposal in response thereto read together, form

the basis for a formal contract to be negotiated and finalised between NHLS and/or its clients and the

enterprise(s) to whom NHLS awards the bid in whole or in part.

5.11.2 Any offer and/or acceptance entered verbally between NHLS and any vendor, such offer shall not

constitute a contract and thus not binding on the parties.

5.12 Instructions for submitting a proposal

5.12.1 Bidders are required to submit one (1) original, one (1) hard copy and 1 (one) electronic copy on a USB

Flash drive in Portable Document Format (PDF) of the Bid shall be submitted on the date of closure of

the Bid.

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Pricing: Bid Price must be submitted in a separate envelop and marked clearly as follows: RFB number,

RFB description and bidder’s name). One (1) original, one (1) hard copy and 1 (one) electronic copy on

a USB Flash drive in Portable Document Format (PDF) of the Bid shall be submitted on the date of closure

of the Bid.

a) Risk assessments should be performed to establish the comprehensive

environmental monitoring programme, i.e. sampling locations, frequency of

monitoring and monitoring methods.

b) These risk assessments should be conducted based on detailed knowledge

of the process inputs and final product, the facility, equipment, the

criticality of specific processes and steps, the operations involved, routine

monitoring data, monitoring data obtained during qualification.

12.2.4. UPS and Power backup for at least 2 hours to ensure data capture during power

failure.

12.2.5. a) Training and Support

a. Risk assessment and needs analysis to cover all essential areas of the

production facility, ensuring compliance with current South African and

RFB: Enclosed:

Closing Date: 30 September 2026

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You are hereby invited to bid for requirements of the (name of department/ public entity)

Bid number: RFB071/24/25 closing date: 30 september 2-026 closing time: 11h00

Outright purchase of building management system/environmental monitoring system (ems)

Description including service and maintenance of the system for a period of five (5) years.

Bid response documents may be deposited in the bid box situated at (street address)

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Is the entity a resident of the republic of south africa (RSA)? yes NO

Does the entity have a branch in the RSA? yes NO

Does the entity have a permanent establishment in the RSA? yes NO

Does the entity have any source of income in the RSA? yes NO

Is the entity liable in the RSA for any form of taxation? Yes NO

If the answer is “NO” to all of the above, then IT is not a requirement to register for a tax compliance status

System pin code from the south african revenue service (SARS) and if not register as per 2.3 Below.

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Members persons in the service of the state.”

Nb: failure to provide / or comply with any of the above particulars may render the bid invalid.

Signature of bidder: ...................................................

Capacity under which this bid is signed: ...................................................

(Proof of authority must be submitted e.g. company resolution)

Date:

...................................................

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1. Confidential information disclosure notice ................................................................................................................ 6

2. Introduction .............................................................................................................................................................. 6

3. Definitions ................................................................................................................................................................. 6

4. Acronyms and abbreviations ................................................................................................................................... 10

5. General Rules and Instructions ................................................................................................................................ 11

6. Response format ..................................................................................................................................................... 15

7. Key personnel .......................................................................................................................................................... 16

8. Reasons for Disqualification .................................................................................................................................... 16

9. Bid Preparation ....................................................................................................................................................... 16

10. Oral presentations and Briefing Sessions ................................................................................................................. 16

11. General Conditions of Bid and Conditions of Contract ............................................................................................. 16

12. Evaluation Criteria and Methodology ...................................................................................................................... 24

ANNEXURE A: Technical Specification ............................................................................................................................... 28

ANNEXURE B: Pricing Schedule .......................................................................................................................................... 33

ANNEXURE C: Bidder’s Disclosure (SBD4) .......................................................................................................................... 36

ANNEXURE D: Preferential Procurement Claim Form (SBD6.1) ......................................................................................... 41

ANNEXURE E: Government Procurement: General Conditions of Contract – July 2011 ...................................................... 53

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3.5 “B-BBEE status level of contributor” means the B-BBEE status received by a measured entity based on its

overall performance using the relevant scorecard contained in the Codes of Good Practice on Black

Economic Empowerment, issued in terms of section 9(1) of the Broad-Based Black Economic

3.6 “Bid” - means a written offer in a prescribed or stipulated form in response to an invitation by an organ

of state for the provision of services, works or goods through price quotations, advertised bidding

processes or proposals.

3.7 “Bidders” - means any enterprise, consortium or person, partnership, company, close corporation, firm

or any other form of enterprise or person, legal or natural, which has been invited by NHLS to submit a

bid in response to this bid invitation.

3.8 “Broad-Based Black Economic Empowerment Act” – means the Broad-Based Black Economic

Empowerment Act, 2003 (Act No. ).

3.9 “Client” - means the goods or services requestor.

3.10 “Comparative Price” - Means the price after the factors of a non-firm price and all unconditional discounts

that can be utilized have been taken into consideration.

3.11 “Consortium” - means several entities joining forces as an umbrella entity to gain a strategic collaborative

advantage by combining their expertise, capital, efforts, skills and knowledge for the purpose of executing

this tender.

3.12 “Contractor Agent” - means any person mandated by a Prime Contractor or consortium/joint venture to

do business for and on behalf of, or to represent in a business transaction, the Prime Contractor and

thereby acquire rights for the Prime Contractor or consortium/joint venture against NHLS or an organ of

state and incur obligations binding the Prime Contractor or consortium/joint venture in favour of NHLS or

an organ of state.

3.13 “Disability” - means, in respect of a person, a permanent impairment of a physical, intellectual, or sensory

function, which results in restricted, or lack of, ability to perform an activity in the manner, or within the

range, considered normal for a human being.

3.14 Designated group means –

(a) Black designated groups;

(b) Black people;

(c) Women

(d) People with disabilities; or

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(e) Small enterprises as defined section 1 of the National Small Enterprise Act, 1996 (Act No. )

3.15 “Designated sector” means – a sector, sub-sector or industry or product designated by the Department

of Trade and Industry.

3.16 “EME” means an Exempted Micro Enterprise in terms of a code of good practice on black economic

empowerment issued in terms of section 9 (1) of the Broad-Based Black Economic Empowerment Act;

3.17 “Firm Price” - means the price that is only subject to adjustments in accordance with the actual increase

or decrease resulting from the change, imposition or abolition of customs or excise duty and any other

duty, levy or tax which, in terms of a law or regulation is binding on the contractor and demonstrably has

influence on the price of any supplies or the rendering cost of any service, for the execution of a contract.

3.18 “Goods” – means any work, equipment, machinery, tools, materials or anything of whatever nature to be

rendered to NHLS or NHLS’s delegate by the Successful Bidder in terms of this bid.

3.19 “Historically Disadvantaged Individual” (HDI) - means a South African citizen:

3.19.1 Who, due to the apartheid policy that had been in place, had no franchise in national elections prior

to the introduction of the Constitution of the Republic of South Africa, 1983, (Act No. ) or

the Constitution of the Republic of South Africa, 1993 (Act No. ) (the Interim Constitution);

and/or;

3.19.2 who is a female; and/or;

3.19.3 who has a disability;

provided that a person who obtained South African citizenship on or after the coming to effect of the

3.20 “Joint Venture” - (Project) means two or more businesses joining together under a contractual agreement

to conduct a specific business enterprise with both parties sharing profit and losses. The venture is for

one specific project only, rather than for a continuing business relationship as in a strategic alliance. It is

about sharing risk with others and providing one or more missing and needed assets and competencies.

3.21 “Management” - in relation to an enterprise or business, means an activity inclusive of control, and

performed on a daily basis, by any person who is a principal executive officer of the company, by whatever

name that person may be designated, and whether or not that person is a director.

3.22 “Military veteran”- has the meaning assigned to it in section 1 of the Military Veterans Act, 2011 (Act No.

).

3.23 “Non-firm Price(s)” - means all price(s) other than “firm” price(s).

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3.24 “Organ of State” - means a National Department or Provincial Administration as stipulated in Schedules

1 and 2 of the Public Service Act, Act (as amended).

3.25 “Person(s)” - refers to a natural and/or juristic person(s).

3.26 “Price”- includes all applicable taxes less all unconditional discounts.

3.27 “Prime Contractor” – means any person (natural or juristic) who forwards an acceptable proposal in

response to this RFB with the intention of being the main contractor should the proposal be awarded to

him/her.

3.28 “Proof of B-BBEE status level of contributor” means -

(a) B-BBEE Status level certificate issued by an authorized body or person;

(b) A sworn affidavit as prescribed by the B-BBEE Codes of Good Practice; and

(c) Any other requirement prescribed in terms of the B-BBEE Act.

3.29 “QSE” - means a qualifying small business enterprise in terms of a code of good practice on black

economic empowerment issued in terms of section 9 (1) of the Broad-Based Black Economic

Empowerment Act;

3.30 “Rand Value” - means the total estimated value of a contract in South African currency, calculated at the

time of invitations and includes all applicable taxes and excise duties.

3.31 “Rural Area” means –

(a) A sparsely populated area in which people farm or depend on natural resources, including villages

and small town that are dispersed through the area; or

(b) An area including a large settlement which depends on migratory labour and remittances and

government social grants for survival and may have a traditional land tenure system.

3.32 “SMME” – bears the same meaning assigned to this expression in the National Small Business Act, 1996

(Act No. ).

3.33 “Stipulated minimum threshold” means – the minimum threshold stipulated for local production and

content.

3.34 “Sub-contract” means - the primary contractor’s assigning, leasing, making out work to, or employing,

another person to support such primary contractor in the execution of part of a project in terms of the

contract.

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3.35 “Subcontractor” - means any person (natural or juristic) who is subcontracted a portion of an existing

contract by a Prime Contractor.

3.36 “Successful Bidder” - means the organization or person with whom the order is placed and who is

contracted to execute the work as detailed in the bid.

3.37 “Township” means – an urban living area that any time from late 19th century until 27 April 1994, was

reserved for black people, including areas developed for historically disadvantage individuals post 27 April

3.38 “Youth” has the meaning assigned to it in section 1 of the National Youth Development Agency Act, 2008

(Act No. ).

24x7 24 hours a day, 7 days a week

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evaluated fairly and in an unbiased manner, in respect of those bidders that achieve the

minimum predefined functionality threshold.

The NHLS only opens the BID / Proposal Section– the first envelope – at the evaluation stage and

only opens the PRICING Section– the second envelope – for those bidders who met the

predefined functionality threshold at the BID section evaluation

5.12.3 Bidders shall submit proposal responses in accordance with the prescribed manner of submissions as

specified above.

5.12.4 Bids must be submitted in a prescribed response format herewith reflected as Response Format, and

be sealed in an envelope clearly marked.

5.12.5 Bids that are too large to fit into the tender box must be handed in at the reception desk during office

hours from 08:00- 16:30 or before 11:00 on the closing date.

5.12.6 All Bids in this regard shall only be accepted if they have been placed in the bid box before or on the

closing date, 30 September 2026 and stipulated time, 11h00 am.

5.12.7 Bids received after the time stipulated shall not be considered.

5.12.8 Bid responses sent by post or courier must reach this office at least 36 hours before the closing date to

be deposited into the proposal box. Failure to comply with this requirement shall result in your proposal

being treated as a “late proposal” and shall not be entertained. Such proposal shall be returned to the

respective bidders.

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5.12.9 No proposal shall be accepted by NHLS if submitted in any manner other than as prescribed above.

Compliance Status letter (with pin) issued by the South African Revenue Services or a CSD Report

reflecting active Tax Clearance Compliance status must be submitted for each member.

6.2.2.2 Central Supplier Database (CSD) Registration Report

6.2.3 Schedule 3: Executive Summary of proposal

6.2.4 Schedule 4: Technical/Functionality (Annexure A)

6.2.5 Schedule 5: Bid Price (to be submitted in a separate envelop and marked clearly as follows: RFB

number, RFB description and bidder’s name) (Annexure B)

6.2.6 Schedule 6: Bidder’s Disclosure SBD 4 (Annexure C)

6.2.7 Schedule 7: Preferential Procurement Claim form and copy of the B-BBEE Verification Certificate(s) issued

by an authorised body or person, or a sworn affidavit prescribed by the B-BBEE Codes of Good Practice.

(Annexure D)

6.2.8 Schedule 8: Bidder Profile:

6.2.8.1 Credentials of the company/consortium members etc.

6.2.8.2 Structure of the company/ consortium members etc.

6.2.8.3 Partnership agreements/contracts

6.2.9 Schedule 9: General Conditions of Contract (Annexure E)

6.3 Bidder background information materials:

6.3.1 Bidder Operating Organisation – Provide an overview of the operating structure and geographical

locations of the firm at the national, regional, and local levels.

6.3.2 Standards – Include information regarding your firm’s utilization of widely known Industry Standards and

guidelines, as they apply to your firm, your firm’s proposal and proposed hardware assets.

6.3.3 Company Contact(s) – Provide the name, title, street address, city, state, telephone and fax numbers and

e-mail of the primary company’s contact person, and for any sub-Contractors.

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6.3.4 Corporate Financial Solvency - Provide solvency statement signed by a qualified independent auditor that

the financial position of the company is sound and that the company will be able to mobilise financial

resources to deliver the project.

7. Key personnel

7.1 Identify key personnel, by employer (include subcontractor(s) and provide contact information.

11.1 Bidders shall provide full and accurate answers to all (including mandatory) questions posed in this

document and are required to explicitly indicate either "Comply/Accept (with a )" or "Do not comply/Do

not accept (with an X)" regarding compliance with the requirements. Where a condition is not applicable,

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an “N/A” option is provided, and bidders must clearly indicate this by marking with an “X”. Where

necessary, the bidder shall substantiate their response to a specific question.

NOTE: It is mandatory for bidders to complete or answer this part fully (11.2 to 11.34); otherwise, their

bid shall be treated as incomplete and shall be disqualified. Refer to paragraph 8 of this document

(reasons for disqualification).

11.2

provide mandatory documents as stipulated in schedule 1 of the Response format.

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11.8

NHLS reserves the right to; cancel or reject any proposal and not to award the Accept Do not Accept

proposal to the lowest bidder or award parts of the proposal to different bidders, or

not to award the proposal at all.

11.9

Caution: If the bidder does not specifically withdraw its own conditions of proposal

when called upon to do so, the proposal response shall be declared invalid.

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11.15

partners of the different enterprises must co-sign this document.

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11.19

outlined in the RFB. Points shall be allocated to each bidder, on the basis that the

maximum number of points that may be scored for price is 80/90, and the maximum

number of preference points that may be claimed for Specific Goals (according to the

PPPFA) is 20/10.

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11.25

12.2.1 The bidder must provide the Qualification documentation for the automated

Building Management System/Environmental Monitoring System (EMS) and its

controls with each milestone of the project:

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• System operation

• Administration and configuration

• Maintenance and calibration

• Data review and reporting

• Ongoing technical support and periodic system health checks.

12.2.6. Five years’ Service and Maintenance of the Environmental monitoring system

(Ems).

environmental monitoring system for a period of five (5) years. The work

includes, but is not limited to:

• Develop, implement and maintain an effective program of the equipment

and outage maintenance work.

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case of any conflict of interest.

13.1.3 The final stage of evaluation is done after the CFET has reached their verdict and is done by NHLS

Procurement Services and separately from the CFET meeting. Points for Specific Goals (commercial

evaluation) is being added in order to get the final order of merit for the bidders being evaluated.

13.1.4 Bidders that score the minimum threshold are recommended and submitted to the NHLS Bid

Adjudication Committee (BAC) for adjudication and the bid MUST be awarded to the bidder who scored

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the highest points (Merit 1) during the CFET and Commercial evaluation (Specific Goals). All the

members of the CFET must complete Declaration of Interest forms and must recuse themselves in case

of any conflict of interest. Should the BAC decide on a bidder other than Merit 1, this decision must be

motivated as a Deviation from NHLS Policy & procedure and Treasury must be advised accordingly.

13.1.5 The CEO of the NHLS must finally approve the recommendation by the Bid Adjudication Committee

(BAC), in his/her capacity as the Accounting Officer.

13.1.6 Details of the successful bidder to be advertised in the National Treasury e-tender portal.

13.1.7 Suppliers must accept the Terms & Conditions of our contract(s) which will result from the RFB

document”. RFB conditions and pricing shall be fixed and firm from RFB closing date to the end of

contract.

13.2 Bid evaluation stages

conditions of Contract.

Substantiation: The bidder must submit and attach to the bid response the signed and accepted NHLS General contract

terms and conditions.

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Proof of Central Supplier Database (CSD) Registration.

Substantiation: The bidder must submit a CSD Report with the bid response.

• Compliant with EU GMP Annex 1 (2023) requirements for environmental monitoring.

• Compliant with 21 CFR Part 11 and EU GMP Annex 11 for electronic data integrity.

Substantiation: The bidder must submit a commitment letter that the supplied system will be Compliant with

EU GMP Annex 1 (2023) requirements for environmental monitoring and 21 CFR Part 11 and EU GMP Annex 11

for electronic data integrity.

Department of Employment and Labour (COIDA).

6. Substantiation: Bidder/Manufacturer must submit and attach a Letter of Good Standing from the Department

of

Labour (COIDA).

13.4 The evaluation of the Bids shall be based on the 80/20 PPPFA principle and the points for evaluation

criteria are as follows:

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Price points 80

Specific Goals 20

Total 100 points

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ANNEXURE A: Technical Specification

System/Environmental Monitoring System (EMS) to continuously monitor and record critical

environmental parameters—particle counts, temperature, relative humidity, differential pressure,

and—within classified areas of the SAVP pharmaceutical manufacturing facility. The system must

comply with EU GMP Annex 1 (2023), 21 CFR Part 11, EU GMP Part 11, GAMP (Good Automated

Manufacturing Practices) 5, and other applicable regulatory guidelines.

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b. Integration of EMS into existing infrastructure including BMS, LMS and Fire

alarm system.

c. Demonstration of data collection, fidelity and retrieval systems including

audit trails, password security and storage facility

d. Demonstration of alarm systems which should include audible and visual

alarms and alerts which are fed through to HMI sms system, email

notification.

e. Validation and verification plan for QT, FAT etc.

f. Training plan.

Substantiation: The bidder must provide a detailed project plan detailing the above items.

2. Bidder must provide 2 contactable reference letters indicating the scope of work

and the facility from 2 pharmaceutical grade facilities.

Substantiation: The bidder must attach two letters on a client’s letterhead.

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.

b) System Overview

• The EMS shall provide real-time, continuous monitoring of environmental

parameters (pressure, temperature, humidity, Total Organic Carbon,

conductivity, particles etc), generate alerts and alarms (Audible alarm

attached to the equipment, SMS, Email) for any excursions, and store all

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1.1 This document may contain confidential information that is the property of the NHLS and the Client.

1.2 No part of the contents may be used, copied, disclosed or conveyed in whole or in part to any party in any

manner whatsoever other than for preparing a proposal in response to this Bid, without prior written

permission from NHLS and the Client.

1.3 All Copyright and Intellectual Property herein vests with NHLS and its Client.

2. Introduction

2.1 Based on the Bids submitted and the outcome of the evaluation process according to the set evaluation

criteria, NHLS intends to select a preferred bidder with the view of concluding a service level agreement

(SLA) with such successful bidder. The Bid shall be evaluated in terms of the Preferential Procurement

Policy Framework Act (PPPFA)

2.2 Queries

2.2.1 Should it be necessary for a bidder to obtain clarity on any matter arising from or referred to in this RFB

document, please refer queries, in writing, and to the contact person email address number listed below

on or before 15 September 2026 Under no circumstances may any other employee within NHLS be

approached for any information. Any such action might result in a disqualification of a response submitted

in competition to the RFB. NHLS reserves the right to place responses to such queries on the website.

Telephone 011 555 0595

Queries:

E-mail [email protected]

• Confidentiality

5.1.1 The information contained in this document is of a confidential nature and must only be used for

purposes of responding to this RFB. This confidentiality clause extends to Bidder partners and/or

implementation agents, whom the Bidder may decide to involve in preparing a response to this RFB.

5.1.2 For purposes of this process, the term “Confidential Information” shall include all technical and business

information, including, without limiting the generality of the foregoing, all secret knowledge and

information (including any and all financial, commercial, market, technical, functional and scientific

information, and information relating to a party’s strategic objectives and planning and its past, present

and future research and development), technical, functional and scientific requirements and

specifications, data concerning business relationships, demonstrations, processes, machinery, know-

how, architectural information, information contained in a party’s software and associated material and

documentation, plans, designs and drawings and all material of whatever description, whether subject

to or protected by copyright, patent or trademark, registered or un-registered, or otherwise disclosed

or communicated before or after the date of this process.

5.1.3 The receiving party shall not, during the period of validity of this process, or at any time thereafter, use

or disclose, directly or indirectly, the confidential information of NHLS (even if received before the date

of this process) to any person whether in the employment of the receiving party or not, who does not

take part in the performance of this process.

5.1.4 The receiving party shall take all such steps as may be reasonably necessary to prevent NHLS’s

confidential information coming into the possession of unauthorised third parties. In protecting the

receiving party’s confidential information, NHLS shall use the same degree of care, which does not

amount to less than a reasonable degree of care, to prevent the unauthorised use or disclosure of the

confidential information as the receiving party uses to protect its own confidential information.

5.1.5 Any documentation, software or records relating to confidential information of NHLS, which comes into

the possession of the receiving party during the period of validity of this process or at any time

thereafter or which has so come into its possession before the period of validity of this process:

5.1.5.1 shall be deemed to form part of the confidential information of NHLS;

5.1.5.2 shall be deemed to be the property of NHLS;

5.1.5.3 shall not be copied, reproduced, published or circulated by the receiving party unless and to the extent

that such copying is necessary for the performance of this process and all other processes as

contemplated in; and

5.1.5.4 shall be surrendered to NHLS on demand, and in any event on the termination of the investigations

and negotiations, and the receiving party shall not retain any extracts.

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• News and press releases

5.2.1 Bidders or their agents shall not make any news releases concerning this RFB or the awarding of the

same or any resulting agreement(s) without the consent of, and then only in co-ordination with, NHLS

and its Client.

5.3 Precedence of documents

5.3.1 This RFB consists of a number of sections (see list). Where there is a contradiction in terms between the

clauses, phrases, words, stipulations or terms and herein referred to generally as stipulations in this RFB

and the stipulations in any other document attached hereto, or the RFB submitted hereto, the relevant

stipulations in this RFB shall take precedence.

5.3.2 Where this RFB is silent on any matter, the relevant stipulations addressing such matter and which

appear in the PPPFA shall take precedence. Bidders shall refrain from incorporating any additional

stipulations in its proposal submitted in terms hereof other than in the form of a clearly marked

recommendation that NHLS may in its sole discretion elect to import or to ignore. Any such inclusion

shall not be used for any purpose of interpretation unless it has been so imported or acknowledged by

dispute arising on any stipulation in the contract.

11.24

the termination of the contract.

11.29

The bidders’ response to this Tender, or parts of the response, shall be included as a Accept Do not Accept

whole or by reference in the final contract.

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11.30

• Design Qualification (DQ)

• Factory Acceptance Test (FAT)

• Installation Qualification (IQ)

• Operations Qualification (OQ)

• Performance Qualification (PQ)

12.2.2. At least 12 months’ warranty documentation.

12.2.3. Bidder must accept drafting and submitting a Risk assessment for the environmental

monitoring system.

Bidders must submit one original, one hard copy, and one electronic copy on USB in PDF. Pricing must be in separate envelope marked clearly. Bids must be in two envelopes: 'BID/Proposal Section' and 'PRICING Section'. Bids too large for tender box must be handed at reception during office hours. Bids sent by post/courier must reach office 36 hours before closing.

Bidders must comply with tax obligations, submit SARS PIN or CSD number. No bids from persons in service of the state or companies with directors in state service. Bidders must submit bids on official forms without changes. Bids must be delivered by stipulated time to correct address; late bids not accepted.

12. Evaluation Criteria and Methodology ...................................................................................................................... 24

2.1 Based on the Bids submitted and the outcome of the evaluation process according to the set evaluation

Policy Framework Act (PPPFA)

minimum predefined functionality threshold.

The NHLS only opens the BID / Proposal Section– the first envelope – at the evaluation stage and

predefined functionality threshold at the BID section evaluation

13.4 The evaluation of the Bids shall be based on the 80/20 PPPFA principle and the points for evaluation

Price points 80

Specific Goals 20

Total 100 points

efforts in this regard during the evaluation of this Tender.

13.1.2 Next steps of evaluation is administrative compliance verification and the “technical” or so called

“functional” evaluation which is purely based on NHLS specifications (Annexure 2) and Scope of Work. NHLS

part of the Cross Functional Evaluation Team (CFET) meeting which is chaired by Quality Assurance (QA).

13.1.3 The final stage of evaluation is done after the CFET has reached their verdict and is done by NHLS

Procurement Services and separately from the CFET meeting. Points for Specific Goals (commercial

evaluation) is being added in order to get the final order of merit for the bidders being evaluated.

13.1.4 Bidders that score the minimum threshold are recommended and submitted to the NHLS Bid

Adjudication Committee (BAC) for adjudication and the bid MUST be awarded to the bidder who scored

the highest points (Merit 1) during the CFET and Commercial evaluation (Specific Goals). All the

13.2 Bid evaluation stages

The bid evaluation process consists of several stages that are applicable according to the nature of the

Stage 1: Administrative Compliance verification

Stage 2: Technical Mandatory requirement evaluation

Stage 3: Technical Functionality requirement evaluation