WHO Basic Training Modules on Good Manufacturing Practices (GMP) - GMP Inspection Process: Module 2 (Part 05): The Inspection
(2006; 35 pages)
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The Inspection

Writing the Inspection Report

  • Each team member writes own part

  • Team leader has overall responsibility

  • Signed by all team members

  • Approval from supervisor

  • To company within 4 weeks or less

If there is an inspection team, each team member writes the part that he/she has inspected and is responsible for. The team leader has the overall responsibility for the final report. He/she must remove inconsistencies between the various parts, and ensure that the sequence of the various parts is logical and the conclusions drawn are valid and founded on facts.

The report is signed by all the team members. It then goes to the supervisor for approval (if required by the country policy or protocol).

The timing of the report is important. If the company has to wait a long time, everyone will have moved on to other things and it will have less impact than if it is delivered promptly. A maximum delivery time should be set by the inspectorate. This could be ten days to 4 weeks maximum.

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Última actualización: le 3 mayo 2013