Upgrade of p2000 radiopharmaceutical production facility to cgmp grade b compliance

• Scope: Upgrade of the existing P2000 Production Facility and HVAC System located in Building P2000 on the NECSA Complex, Pelindaba, North-West Province.
• Key objectives: Modify layout to establish a Grade B environment in the Radiochemistry room, improve personnel and material flow, upgrade/replace HVAC system, and upgrade facility surface finishes.
• Exclusions: Cyclotron technical area and hall upgrade are excluded.
• Compliance: Must comply with ISO 14644, WHO, PIC/S, SAHPRA standards, and cGMP for aseptic manufacturing of fluorine-based radiopharmaceuticals.
• Facility details: Approximately 255 m2 single-storey concrete building with areas including Cyclotron rooms, Radiochemistry Room (Grade C at-rest), change rooms, dispatch, and AHU area.
• System classification: Classified as Direct Impact (quality critical) systems requiring commissioning and qualification (DQ, IQ, OQ, PQ) per ISPE guidelines.
• Key requirements: Defined in tables covering compliance, process capacity, product properties, critical quality attributes, design considerations, equipment, utilities, operations, and life-cycle.
• Supplier responsibility: Must perform an assessment of the existing facility to determine upgrade scope and ensure all legal, compliance, safety, and regulatory requirements are met.

• The URS is not an exclusive approach; suppliers are welcome to identify omissions or propose alternative suggestions.
• The document is intended to facilitate understanding of needs and proposing suitable designs.

• The upgrade must comply with ISO 9001:2015 Quality Management System requirements.
• Quality Assurance (QA) and Quality Control (QC) are integral, with references to QA Reviews and approvals.
• Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) are defined for the product (F-18 FDG radiopharmaceutical).
• Filter integrity testing must meet ISO 14644 Part 3 acceptance criteria.
• Air change rates must provide a clean-up period of less than 20 minutes.
• Commissioning must be performed by accredited or qualified personnel.
• Installed systems and components must be included in NTP’s In-service Inspection and Maintenance Plan (ISI&MP).
• Instruments must be added to the ISI&MP and calibrated at determined frequencies.

• The upgrade must comply with a comprehensive list of standards and regulations, including:

• Occupational Health and Safety Act.
• ISO 14644 series for cleanrooms.
• ISO 17873-2004 for nuclear ventilation systems.
• ISPE guides for commissioning, qualification, and HVAC.
• PIC/S guides for GMP for medicinal products (Part I, Annexes 1, 3, 15).
• SAHPRA Guideline on GMP for Medicines.
• SANS standards for lighting, building regulations, and wiring.
• NECSA internal SHEQ instructions for ventilation, hazardous chemicals, radiological areas, waste management, ALARA, and access control.
• WHO technical reports for GMP covering hazardous substances, HVAC, validation, radiopharmaceuticals, and sterile products.

• The facility must be designed to meet cGMP requirements for sterile radiopharmaceutical manufacturing.
• The supplier is responsible for complying with all South African laws and municipal by-laws, even if not explicitly listed.
• The supplier must conduct Quality Risk Management (QRM) analyses for design decisions.

• Compliance with the Occupational Health and Safety Act (OHSA) is mandatory.
• The facility must include adequate space and access for safety equipment: isolation switches, fire extinguishers, safety showers, and first-aid facilities.
• Design must consider radiation protection, ALARA compliance, and controls to minimize microbial contamination.
• Areas for handling radioactive materials and hazardous chemical substances (HCS) must be appropriately designed and demarcated.
• Emergency showers and handwash basins are required in change rooms and radiological areas.
• Lighting must meet SHEQ-INS-1120 and SANS 10114-1, with emergency lighting for safe evacuation.
• Only Necsa-approved suppliers and equipment may be used for electrical installations, requiring a Certificate of Compliance.
• Fire detection and protection systems must comply with SHEQ-INS-2500 and SANS 1186-1.
• Safety systems and access control are required per SHEQ-INS-8920.

• The supplier must comply with all South African environmental Acts and laws, even if not explicitly listed in the document.
• The facility design must ensure proper classification and monitoring of cleanrooms and controlled areas per ISO 14644 and PIC/S Annex 1.
• Waste management systems are required for hazardous chemical waste and solid radioactive waste.
• Hazardous waste must be stored in original containers prior to removal by a licensed contractor.
• The layout must allow for safe and easy removal of effluent from the facility.

• The prospective service provider is responsible for ensuring all legal, compliance, safety, and regulatory requirements are met in their proposed quote/scope of work.
• They must request further information if anything is unclear to ensure their quote is final and executable.
• They must perform Quality Risk Management (QRM) analyses for design decisions.

The document does not provide specific tender evaluation criteria. It mentions Quality Assurance Review and references the validation life cycle including Design specification, Quality Risk Management (QRM), and Commissioning and Qualification (C&Q) activities.

Closing date: 31 July 2026 at 11:00. Bid validity period: Offer must remain valid for the number of days specified in the pricing schedule from the closing date.

Bidding procedure enquiries: Mr Fhatuwani Mukwevho. Telephone: 012 305 5531. Email: [email protected]. Submission address: Bid box at Necsa Gate 3, R104 Elias Motsoaledi Street (Church Street West Ext), Pelindaba.

Submit bids by the closing date and time (31 July 2026, 11:00) to the bid box at Necsa Gate 3, R104 Elias Motsoaledi Street (Church Street West Ext), Pelindaba. Bids must be on official forms provided (not re-typed). Late bids will not be accepted. Required returnable documents include: signed bid form (SBD 3.2, SBD 6.1, SBD 7.1), pricing schedule, tax clearance certificate (TCS PIN or CSD number), B-BBEE status verification certificate or sworn affidavit (for EMEs/QSEs), declaration of interest, and proof of authority (e.g., company resolution). Failure to comply with any requirement may render the bid invalid.

Design and upgrade an existing Grade C production facility to a cGMP-compliant Grade B facility. Compliance with all specified technical and regulatory standards is mandatory. Failure to provide or comply with any required particulars may render the bid invalid.

Pricing must be submitted on the official SBD 3.2 pricing schedule. Offers must remain valid for the specified number of days from the closing date. Payment terms: 30 days after receipt of invoice and delivery note. All applicable taxes must be included in the price. Bidders are responsible for ensuring pricing accuracy; errors are at their own risk.

Mandatory compliance: Tax clearance (TCS PIN or CSD number). B-BBEE status verification certificate or sworn affidavit (for EMEs/QSEs) required to claim preference points. Bidders must declare any conflicts of interest (e.g., state employment, relationships with procuring institution staff). Bidders listed in the Register for Tender Defaulters or Restricted Suppliers will be disqualified. Foreign suppliers must complete the foreign supplier questionnaire if applicable. Consortia/joint ventures must submit separate compliance documents for each party.

All notices, communications, and submissions must be sent to the domicilium citandi et executandi (legal address) specified in the SLA. Contact persons are designated in the SLA for project-related queries. Notices are deemed received:

• Immediately if delivered physically.
• 7 days after posting if sent by registered mail.
• On the day of transmission if sent by facsimile or email.

Submit the following returnable documents as part of your bid:

• Service Level Agreement (SLA) addressing specific conditions for the services, amplifying or amending the standard Terms and Conditions of Contract.
• Ensure all attachments and appendices referenced in the SLA are included.
• Where the SLA conflicts with the standard Terms and Conditions, the SLA provisions take precedence.

Scope of work:

• Design and upgrade an existing Grade C production facility to a cGMP-compliant Grade B facility.
• Develop and adhere to a Project Plan and Schedule of Deliverables (Annexure B in SLA), outlining activities, deliverables, and milestones.
• Submit interim and final reports as deliverables at stages agreed upon in the SLA.
• Non-conforming deliverables must be corrected promptly at the Service Provider's expense.
• Services must comply with NECSA’s specifications and cGMP standards.

Methodology requirements:

• Develop a Project Plan and Schedule of Deliverables (Annexure B in SLA) outlining activities, deliverables, and milestones.
• Submit a Proposal (Annexure A in SLA) detailing the proposed course of action, solutions, and resources required.
• Services must be completed in accordance with the Project Plan. Variations require written agreement between parties.
• Delays beyond essential timeframes may result in NECSA engaging another service provider at the defaulting party’s expense.

Quality management and acceptance:

• NECSA has 7 days (Evaluation Period) to verify deliverables conform to requirements.
• Non-conformities must be reported in writing before the Evaluation Period ends. Service Provider must correct at its own expense.
• NECSA has an additional 7 days (Verification Period) to confirm corrections.
• Deliverables are deemed accepted if no notification of non-conformity is issued within the Evaluation or Verification Periods.
• NECSA may assist the Service Provider in verifying and correcting non-conformities.

Pricing and payment details:

• Fees are specified in the Pricing Schedule (Annexure E in SLA).
• Payment is contingent on full performance and acceptance of services and deliverables.
• Monthly statements and invoices must be submitted by the last day of each month.
• Payments are processed within 30 days of correct documentation submission via electronic transfer.
• Retention fee of 10% may apply, payable within 3 months of final acceptance.
• Additional expenses (e.g., travel, accommodation) must be invoiced separately if not included in fees.

Payment terms and conditions:

• Fees are outlined in the Pricing Schedule (Annexure E in SLA) and are payable only after full performance and acceptance of services and deliverables.
• Submit a monthly statement, original invoice, and associated documents by the last day of each month for fees due.
• Payments are processed within 30 days of receiving correct documentation via electronic bank transfer.
• NECSA may withhold a 10% retention fee, payable within 3 months of receipt of all goods/services and issuance of a certificate of acceptance.
• Travel, accommodation, and disbursement expenses (if not included in fees) must be invoiced separately, following the same submission and payment process.
• Penalties for late delivery: NECSA will deduct a sum calculated per the Penalty Formula (Annexure D in SLA) for each day of delay until delivery or performance.

Mandatory compliance requirements:

• Tax clearance certificate: Original certificate issued by SARS must be submitted before contract award. No contract will be concluded with bidders whose tax matters are not in order.
• Local Service Providers are responsible for all taxes, duties, and license fees until delivery of goods to NECSA.
• Foreign Service Providers are responsible for all taxes, stamp duties, and levies imposed outside South Africa.
• Preference must be given to Black Empowerment Companies as subcontractors. Notify NECSA in writing of all subcontracts awarded.
• Service Provider must ensure all personnel are aware of the legal implications of Section 51 of the Nuclear Energy Act, 1999, and have signed confidentiality agreements.

B-BBEE requirements:

• Service Providers must give preference to Black Empowerment Companies as subcontractors.
• Notify NECSA in writing of all subcontracts awarded, including those to Black Empowerment Companies.

Key contractual terms:

• The contract is governed by South African law and all documents must be in English.
• Neither party may act as an agent for the other without written authorization.
• Assignment or subcontracting of any part of the contract requires prior written consent from NECSA.
• Subcontracting must prioritize Black Empowerment Companies.
• Contract amendments must be in writing and signed by both parties.
• Force Majeure: Neither party is liable for failures caused by events beyond reasonable control (e.g., natural disasters, strikes, terrorism).
• Termination: Either party may terminate for insolvency, judicial management, or unpaid judgments after 14 days.
• Dispute resolution: Escalate disputes first to project managers, then to executive managers. If unresolved, parties may pursue legal rights.
• Breach of contract: Aggrieved party may claim specific performance or terminate the agreement and claim damages after a 7-day notice period.
• Non-solicitation: Parties may not employ or solicit each other’s personnel for 6 months post-contract. Breach incurs damages equal to 6 months' salary of the solicited personnel.
• Confidentiality: All information, reports, and data must be kept confidential and used solely for contract performance. Personnel must be aware of Section 51 of the Nuclear Energy Act, 1999.
• Intellectual Property: NECSA retains ownership of its data. Service Provider retains ownership of its intellectual property but grants NECSA a royalty-free, perpetual license for use in deliverables.
• Warranties: Goods must be new, unused, and incorporate recent improvements. Warranty period is 12 months post-delivery or 18 months post-shipment, whichever is earlier.
• Insurance: Goods must be fully insured against loss or damage during manufacture, acquisition, transportation, storage, and delivery.
• Indemnity: Service Provider indemnifies NECSA against loss, damage, third-party claims, and legal costs arising from breach of warranties or intellectual property infringements.

Special conditions:

• Service Level Agreement (SLA) may be provided to address specific service conditions, amplifying or amending standard Terms and Conditions.
• In case of conflict, SLA provisions supersede standard Terms and Conditions.
• SLA includes Annexures such as Pricing Schedule (E), Project Plan (B), Order (C), and Penalty Formula (D).

Deliverables are evaluated during a 7-day Evaluation Period. Non-conformities must be corrected within a 7-day Verification Period. Acceptance is automatic if no issues are raised within these periods.