WHO prequalification of a quality control laboratory consists of:
- assessment of a laboratory information file or quality manual
- on-site inspection.
Assessment of laboratory information
The laboratory information provided is assessed to ascertain whether WHO Good Practices for Quality Control Laboratories, WHO Good Practices for Pharmaceutical Microbiological Laboratories, and the relevant parts of Good Manufacturing Practices as recommended by WHO for such laboratories (relating to transfer of technology in pharmaceutical manufacturing (analytical method transfer), validation, sterile pharmaceutical products, heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms and water for pharmaceutical use) are being adhered to.
If the results of the assessment are positive, the QCL is recommended for inspection, to assess compliance with WHO-recommended standards for QCLs. Alternatively, the QCL may submit the report of an inspection or audit performed by a regulatory authority that applies standards at least equivalent to WHO-recommended quality standards for quality control laboratories referred to above, and its response to any observations made by the authority during inspection or audit. The inspection may then be waived.
Invitation to submit an expression of interest
Good practices for pharmaceutical quality control laboratories
Good practices for pharmaceutical microbiology laboratories
Good Manufacturing Practices relevant to QCLs