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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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View the documentThe Inspection
View the documentThe Inspection
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View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
View the documentThe Inspection
 

The Inspection

Report with Covering Letter to Company

  • Any corrective actions to be taken

  • Time limits for implementing them

  • Confidential information

  • Exchange of reports

  • Regulatory measures if not implemented

After the report has obtained supervisory approval, it should be sent with a covering letter to the company management. As said earlier, this should be done not later than 4 weeks after the inspection, earlier if possible. If the report concludes that improvements and corrective actions need to be implemented, these can be summarized in the letter or pointed out in the report.

Time limits for carrying them out should be given, and the consequences of not doing so can be pointed out. (Corrective actions and time limits should have been discussed in the exit meeting, but a formal, written statement should be made when the report is sent to the company).

Inspection reports are normally treated as confidential documents, depending on national legislation. However, under certain international agreements, reports are exchanged between regulatory authorities (e.g. mutual recognition agreements, memoranda of understanding or signatories to co-operation schemes).

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Last updated: May 3, 2013