Tender Summary: SAHPRA/2026/Microbiological Testing Laboratory – Small Molecules

Objectives

The primary objective is to appoint a competent, accredited independent laboratory to conduct microbiological testing of regulatory samples for small-molecule medicines on behalf of the South African Health Products Regulatory Authority (SAHPRA). This appointment supports SAHPRA’s statutory mandate for quality surveillance, risk assessment, and regulatory decision-making regarding medicines and health products, filling a gap in SAHPRA’s current in-house microbiology capabilities.

Scope

The service encompasses microbiological testing of regulatory samples as directed by SAHPRA, covering routine analysis, urgent regulatory testing, investigations into suspected falsified or substandard products, and critical public health inquiries. The exact testing parameters will be determined by SAHPRA based on product type, risk classification, suspected quality defects, and applicable pharmacopoeial standards. Bidders must quote for the complete requirement; partial or selective submissions will be rejected.

Technical Requirements

• Maintain valid ISO/IEC 17025 accreditation with an explicit, current microbiology scope.
• Demonstrate adequate laboratory infrastructure, floor plans, and calibrated equipment suitable for the volume and type of regulatory samples.
• Implement strict chain-of-custody protocols, secure sample storage, temperature monitoring, and traceability linking SAHPRA sample numbers to laboratory identification codes.
• Adhere to validated pharmacopoeial or WHO-approved methods; clearly identify and provide technical justification for any tests falling outside the accredited scope.
• Enforce data integrity principles compliant with ALCOA+ standards across all electronic and manual records.
• Establish documented procedures for handling out-of-specification (OOS) results, ensuring investigations follow approved scientific protocols rather than arbitrary retesting.
• Deliver formal Certificates of Analysis directly to SAHPRA, prohibiting direct communication with manufacturers unless expressly authorized.
• Meet defined turnaround times: approximately 20 working days for routine testing, 10 days for urgent cases, 5–10 days for suspected falsified products, and ad-hoc timelines for critical public health investigations.
• Maintain sufficient operational capacity, participate in external proficiency testing, and submit to SAHPRA audits. Subcontracting requires prior written approval.
• Uphold strict confidentiality, retain records per legislative requirements, and maintain documented business continuity plans.

Skills Requirements

• Employ a sufficient number of qualified microbiology professionals capable of executing and authorizing regulatory tests.
• Provide detailed curriculum vitae (CVs) of all assigned specialist personnel who will conduct or oversee onsite testing.
• Submit documented standard operating procedures (SOPs) and method validation evidence demonstrating technical competence in microbiological analysis.
• Maintain comprehensive training and competency assessment records for all staff involved in SAHPRA testing; only assessed-competent personnel may perform or authorize tests.
• Supply reference letters from previous clients verifying past performance in microbiological testing, with prior experience supporting national regulatory authorities or control laboratories highly advantageous.
• Achieve a minimum functional score of 65 out of 100 points during evaluation, which assesses company experience, reference letters, SOP documentation, and specialist qualifications.

Unusual or Complicated Terms

• Blinding of Regulatory Samples: A procedural safeguard where sample identifiers are masked to conceal manufacturer or product details, ensuring unbiased, impartial testing results free from commercial influence.
• Out-of-Specification (OOS) Results: Unexpected analytical outcomes that trigger a formal, documented investigation protocol. Tests cannot be automatically invalidated or repeated solely because initial results fall outside expected ranges; all repeat testing must follow approved scientific procedures and be communicated to SAHPRA.
• ALCOA+ Data Integrity Principles: A regulatory standard requiring all analytical records to be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available throughout the testing lifecycle.
• 80/20 Preference Point System: A public procurement scoring model where 80% of evaluation points are allocated to price competitiveness and 20% to designated socio-economic transformation goals, such as Black Economic Empowerment (B-BBEE) status, support for small, medium, and micro-enterprises (SMMEs), and historically disadvantaged individuals (HDIs).