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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
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

What to Record - I

  • Persons interviewed

  • Document numbers

  • Equipment numbers

  • Item identification

There are a few specific things that you need to record wherever they are appropriate:

  • The persons being interviewed - their names and job titles and/or responsibilities. (You may also want to evaluate the SOP for training and training records of personnel. It will he helpful if you have recorded names of operators during the inspection, when you assess training records later. You can then verify that an operator had been receiving continued training).

  • The reference number of any document that is reviewed - both the issue number and specific batch number if applicable (e.g. SOP numbers).

  • The reference number of any equipment that you are looking at and that will be the subject of a comment in your report. You could also select a piece or pieces of equipment to evaluate compliance with the planned preventative maintenance program later during the inspection.

  • Any other relevant reference numbers, for example room numbers or instrument codes should be recorded.

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Last updated: May 3, 2013