Medicines Quality Control Laboratories
WHO prequalification of a quality control laboratory (QCL) 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.