Specialised technical advisory services for gmp certification of obp vaccine facility

Closing date: 02 July 2026 at 13:00. Compulsory briefing session: 12 June 2026 at 11:30. Bids must remain valid for 120 days after closing.

Queries: [email protected]. Department: of Agriculture.

To avoid automatic disqualification, submit the following compulsory documents: a ticked checklist of required documents, proof of CSD registration, valid tax compliance certificate, certified ID copies of key personnel, and detailed CVs for the project team. All qualifications must remain valid for 3 months from submission. South African bidders must submit physical copies. International bidders without local offices may submit via fax or email but must provide original signed documents within 3 working days after closing. Bids must be in ZAR and remain valid for 120 days post-closing. Use black ink for signatures, number all pages, and label the tender envelope and documents with the bidder’s name and address. Direct queries to [email protected] at least 11 working days before closing.

Evaluation occurs in 3 stages:

Stage 1: Compulsory document check – missing documents result in automatic disqualification.

Stage 2: Functionality evaluation (minimum 80/100 required to proceed). Criteria and weights:

• Company profile (15 points): GMP experience scored 0-5 based on years active in GMP environments, project list, and reference letters.
• Financial stability (10 points): Annual Financial Statements (AFS) not older than 18 months, Current Ratio ≥ 1.0, Going Concern status.
• Reference letters (15 points): Minimum 3 letters, at least 1 from a GMP-certified facility, all within the last 10 years.
• Specialist team (30 points): All 16 required roles must be filled with valid professional registrations (e.g., SACAP, ECSA, SACQSP, SACNASP). Each specialist must have 5-10+ years of GMP experience and at least 2 contactable references.
• Methodology (30 points): Technical proposal must include a step-by-step method statement, risk plan, project timeline/Gantt chart, and resource plan (RACI matrix).

Stage 3: Price (80 points) and BBBEE (20 points) under the 80/20 PPPFA principle. BBBEE points: 10 for 51%+ black ownership, 8 for 30%+ women ownership, 2 for disability ownership (requires valid BBBEE certificate or equivalent proof).

Objective: Appoint a GMP Advisor/Principal Engineering Consultant to evaluate OBP’s current infrastructure, define modifications, estimate costs, and draft a roadmap to achieve GMP certification. Project is divided into two phases: Initial Services (4 months) and Ongoing Services (36 months).

Scope:

• Facility Assessment & Gap Analysis: Document review of SOPs, batch records, QMS; infrastructure audit of HVAC, purified water, compressed air, facility layout, and equipment; gap analysis report.
• Design & Engineering Oversight: Conceptual/basic design review for architectural, HVAC, and process piping; process optimization; URS development for equipment and automation.
• Project Execution & Commissioning: Vendor oversight; commissioning support.
• Qualification & Validation Strategy: Validation Master Plan (VMP) for IQ/OQ/PQ; compliance sign-off.
• Ongoing Services: Independent oversight of principal agent, contractor, and sub-contractors; training & capacity building (GMP training programs, knowledge transfer); review of consultants’ documentation; periodic updates and reports until GMP certification is obtained.

Deliverables: Comprehensive Facility Gap Analysis & Action Plan, Master Upgrade Design & Finalized URS Documents, Validation Master Plan (VMP), Final Close-out Report & Readiness Assessment for Regulatory Audit.

Specialists required: 16 roles including Architecture, GMP Auditor, Mechanical, Structural/Civil, Electrical, Instrumentation, Process, Quantity Surveyor, Cleanroom, Molecular Diagnostics/Vaccines, Environmental, Fire Safety, HVAC, Clean Utilities, Process Architecture, and Quality Assurance. All roles requiring statutory registration must be fully compliant.

Methodology requirements for the technical proposal:

• Submit a comprehensive method statement tailored to both initial review and ongoing operational services phases.
• Include a risk plan with identified project risks and mitigation strategies.
• Provide a project plan with timelines, milestones, or a Gantt chart.
• Include a resource plan (RACI matrix) with detailed role mapping for each team member.
• Higher scores awarded for comprehensive resource management plans and GMP-specific risk contingencies.

All 16 specialists listed in the document must form part of the project team. Qualifications must remain valid for 3 months from the submission date. Failure to comply results in automatic disqualification. Required: certified ID copies and detailed CVs for all specialists. Fraudulent or inaccurate information (e.g., fake memberships, BBBEE credentials, or experience) will result in disqualification. International bidders without local offices may submit via fax or email but must provide original signed documents within 3 working days after closing.

Quality management requirements include:

• Monitoring and evaluating the performance of the principal agent, principal contractor, and sub-contractors.
• Designing and delivering tailored GMP training programs covering aseptic techniques, contamination control, and QMS management for facility personnel.
• Establishing knowledge transfer and ongoing quality assurance/maintenance monitoring schedules.
• Reviewing consultants’ documentation and designs, reporting insights to OBP during all project phases (design to handover).
• Attending project update meetings as required by OBP and providing updates and advice.
• Services must continue until GMP certification is obtained.

Pricing must be fixed in ZAR. Submit three quotes:

• Quote 1: Initial Services (4 months) – experts’ time + disbursements (travel for site meetings), VAT 15% included, invoiced monthly in arrears.
• Quote 2: Ongoing Services (36 months) – experts’ time + disbursements, VAT 15% included, invoiced monthly in arrears.
• Quote 3: Total Cost – combined initial and ongoing services over 40 months, VAT 15% included, invoiced monthly in arrears.

Each quote must include itemized costs (excl. VAT), disbursements, total excl. VAT, VAT 15%, and total incl. VAT. Selected bidders may be required to present their proposal at OBP premises at their own expense.

Pricing must be fixed in ZAR and remain valid for 120 days post-closing. Submit three quotes:

• Quote 1: Initial Services (4 months) – experts’ time + disbursements for travel, VAT 15% included, invoiced monthly in arrears.
• Quote 2: Ongoing Services (36 months) – experts’ time + disbursements, VAT 15% included, invoiced monthly in arrears.
• Quote 3: Total Cost – combined initial and ongoing services over 40 months, VAT 15% included, invoiced monthly in arrears.

Price schedule must include itemized costs (excl. VAT), disbursements, total excl. VAT, VAT 15%, and total incl. VAT. Selected bidders may be required to present their proposal at OBP premises at their own expense.

Must be registered on the Central Supplier Database (CSD) and tax compliant. Valid BBBEE certificate required (51%+ black ownership for 10 points, 30%+ women ownership for 8 points, disability ownership for 2 points). Annual Financial Statements (AFS) not older than 18 months, including cash flow statement, income statement, and balance sheet, signed and compiled per Companies Act. Minimum 3 reference letters (at least 1 from a GMP-certified pharmaceutical facility), all within the last 10 years, on client letterhead with contact details, scope of work, facility type, and completion dates. All 16 specialist roles must have valid professional registrations where applicable (e.g., SACAP for architects, ECSA for engineers, SACQSP for quantity surveyors, SACNASP for environmental specialists). Proof of COID registration may be required. Subcontractors must be disclosed with registration details. Fraudulent or inaccurate information will result in disqualification.

Bidders must arrive on time for site visits and wear PPE clothing before entering OBP premises.

Tender forms must not be retyped or redrafted; photocopies are acceptable but must include original signatures in black ink. Bidders must verify all pages are present and numbered. The offer remains binding for the validity period (120 days from closing). South African law governs the contract, and bidders must accept full responsibility for execution and fulfillment of obligations. Any pricing errors or miscalculations are at the bidder’s risk. Queries must be sent to [email protected] at least 11 working days before closing.