While many of the documents published by the FDA are available to the
public (due to the Freedom of Information, FOI), unfortunately this is
very rare in the EU.One of the few exceptions to the rule is a document
titled
"Compilation of Community Procedures on Inspections and Exchange of Information"
published by the EMEA, the European registration authority, even in 2003. It is the objective of this document to pave the way for
standardised official inspections within the EU. This document was revised
last year and at the beginning of this year and has now as many as 95
pages. In the following you can read a short summary of the document's
part on inspections of pharmaceutical manufacturers (pages 27-41) since especially this part can give useful advice to pharmaceutical
manufacturers.
The chapter on the "Conduct of Inspections of Pharmaceutical
Manufacturers" comprises 15 pages and, after a short introduction and
a glossary, describes:
- General Considerations on Inspections
- Inspection Procedures
- Final Meeting
- Inspection Report
- Inspection Frequency
- QM of the Inspector's Activity
Two annexes on the conduct of product-related inspections and on
inspections for investigational medicinal products complete the chapter.
The item "Inspection Procedures" is further divided into
subchapters. These subchapters deal in detail e.g. with the inspector's
preparation prior to the inspection. What should he possibly have a look
at beforehand (e.g. Site Master File)? What should the inspection plan
look like? How should he/she conduct the opening meeting? What does the
inspector expect from the manufacturer within the framework of the
opening meeting?
This question is especially important for the pharmaceutical
manufacturer in order to prepare adequately for the opening meeting.
How should an inspection be conducted on site, how a document review be
done? Which documents are usually examined during a general GMP-orientated
inspection, which ones are checked in a product-related inspection?
Which kind of information does the inspector expect with regard to
contract manufacture and analysis, complaints and product recall, or
self-inspections?
At the end of the document, in Appendix 2, you can find the CPMP/CVMP
summary report on GMP inspections carried out under the centralised system.
Conclusion: The document can help you prepare for an official
inspection if you are willing to change your perspective and see things
from the inspector's point of view.
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