(2003; 148 pages)
2.5 Site Inspection
Dependent on the outcome of the evaluation of the product dossier, WHO will plan and co-ordinate performance of inspections at the manufacturing sites to assess compliance with Good Manufacturing Practices as recommended by WHO (2). The inspection will be performed by a team of inspectors consisting of experts appointed by WHO, preferably from Regulatory Authority Inspectorates. The experts will be of three main areas including production, quality control and GMP. A WHO staff member will co-ordinate the team and the team members will act on a temporary basis as expert advisers to WHO. The team(s) will perform the inspections and report on the findings in accordance with SOP’s established by WHO for planning and performing site inspections to ensure a standard harmonized approach. The WHO GMP checklist will be used during the inspection.
A representative(s) of the DRA of the country of manufacture would normally be expected to accompany the team to the manufacturing and testing facility to assess the compliance with GMP.
Evaluators and inspectors must have the relevant qualifications and experience.