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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
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

How to Record - I

  • Checklists

  • Flowcharts/process charts

  • Symbols such as a star (*) or a tick

  • Checks and follow-up

There are a number of ways in which records and notes can be made during the inspection. The one that you choose will depend on what is most appropriate at the time, the inspectorate policy and your personal choice. The following are just some suggestions from personal experience:

  • Checklists are a detailed, but structured way of taking notes. We will look at these in more detail in a few moments.

  • Flow-charts can be a good way of making sure that you understand an operation and how it fits into the overall system. The flow-chart approach can also be useful for understanding the process of manufacturing itself.

  • Use of symbols may make your notes easier to interpret when they are read back. For example, you could make use of a square drawn round items for the report; or a star to indicate items for follow-up and checking at a later stage during the inspection.

Each inspector has his/her own way of making sure that everything asked for during the inspection is shown, or presented or followed up before the end of the inspection. These observations can be recorded on a separate page (marked “checks”) or the observations can be marked with an asterisk on the far right of the page. These can then be ticked off when followed up or presented. Which ever system you use, make sire that documents, results and other things asked for during the inspection, are presented to you before you finalise the inspection. If these are not presented to you, they may not exist, or the company had forgotten to show them to you. However, you can not assume, and can then not report on the matters.

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Last updated: May 3, 2013