During the week of 16 to 19 September 2024, an audit team from the World Health Organization (WHO) Laboratory Networks and Services Team within the Regulation and Safety Unit at the WHO Headquarters visited Namibia. This audit was conducted to assess the readiness for the process of prequalification, in response to the efforts and commitment demonstrated by the Quality Surveillance Laboratory (QSL) of the Namibia Medicines Regulatory Council (NMRC) to achieve the WHO Prequalification of Pharmaceutical Quality Control Laboratories (QCLs). The visit was facilitated by an invitation from the Ministry of Health and Social Services (MoHSS).

The QSL has previously submitted an expression of interest (EoI) for WHO Prequalification of Pharmaceutical QCLs. To become prequalified, a QCL must demonstrate adherence to WHO Good Practices for Quality Control Laboratories (GPPQCL) and other WHO Guidelines. Being listed on the WHO List of Prequalified QCL signifies that the QSL meets the WHO and internationally recommended quality standards, joining several other QCLs globally.

The audit involved a comprehensive assessment through interviews, document reviews including the laboratory information file (LIF) and monitoring of technical performance by witnessing tests through a visit to the facilities and a thorough revision of the Quality Management System (QMS), in accordance with WHO GPPQCL and related guidelines. The evaluation covered test-related documentation such as SOPs, samples and reagents handling, equipment qualification, control charts, validation and verification data, internal and external quality control, data trend analysis, test results and investigations into out-of-specification along with a vertical audit.

The testing activities conducted under the scope included basic chemical tests, identification using HPLC, UV-Vis, FTIR and TLC; physical/chemical analysis through appearance and pH assessments; Assay by HPLC, Assay by UV-Vis and Assay by volumetric titration for Assay and Potency; and Uniformity of weight, Uniformity of dosage units (Mass variation, Uniformity of content), Friability, Disintegration and Dissolution for Pharmaceutical technical procedures. 

The audit highlighted positive findings and offered valuable opportunities for improvement as the Quality Surveillance Laboratory prepares for the next steps toward accreditation. Although it identified some non-conformities, it also acknowledged the significant efforts and commitment of the QSL in achieving this important milestone.