GMP News No. 608
20 September 2005
Revision of the EMEA Inspection Guideline
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:
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.
Are you interested in further advice on how to deal with official
inspections? We have designed an event for you that focuses especially on
How to Pass EU and FDA
An inspector from the British authority MHRA will give you first-hand information on his experiences with EU inspections.