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

Remember that an Inspection....

  • Is a systematic approach

  • Involves interpersonal skills

  • Identifies deficiencies

  • Looks at what went wrong

  • Requires participation from both parties

There are number of things that you need to remember about an inspection:

First of all, inspection is a systematic approach. As you will be assessing compliance with GMP guidelines, it is recommended that you have a systematic approach to assist you in remembering all the aspects that need to be assessed.

You need to have good interpersonal skills in order to get the best out of the people you are talking to.

An inspection should identify deficiencies ... and that means looking at what is wrong, or what went wrong.

An inspection requires participation from both parties - there isn’t much point in asking lots of questions if they are not going to be answered.

You must also listen to the answers and evaluate them carefully. There is no point in asking a question and then not listening to the response. Frequently, the response will lead to the next question.

Expect the company to know more about its equipment, facilities and processes than you do. Ask relevant questions in all the areas about the processes, procedures, systems and equipment.

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Dernière mise à jour: le 3 mai 2013