SOP by EMEA on Inspections

GMP News No. 621

GMP News
11 October 2005

SOP by EMEA on Inspections

In our GMP News of 20 September 2005 we informed you about the chapter "Inspections" of the EMEA document "Compilation of community procedures on inspections and exchange of information". It is the objective of this document to enable harmonised official inspections in the EU.

This document is complemented by an SOP issued by EMEA, which describes the harmonisation and conduct of GMP- and product-/process-related inspections of an application for marketing authorisations under the centralised system ("Procedure for co-ordinating pre-authorisation GMP and product/process- related inspections").

By means of highly detailed lists, this SOP describes the correct procedures for the topics "Pre-submission Meetings", "Validation of the application by Inspections Sector", "Submission and GMP compliance", "Preparation of GMP Inspection Request", "Pre-authorisation Sampling and Testing", "Initiation of a GMP Inspection and/or Sampling and Testing" and "Inspections reports". This list of actions is complemented by a column titled "Responsibility". 

Even though this SOP has, of course, been written for authority representatives, it is worthwhile reading also for members of the pharmaceutical industry. The column "Responsibility" lists e.g. also the person handing in the application or the firm to be inspected. Besides, the procedure for writing the report is described in detail. Flow charts help to illustrate the whole way of proceeding. Another table list the individual steps once more for post-authorisation inspections - including the necessary intervals for re-inspections. This table is also very helpful, as it shows in which periods the pharmaceutical companies have to prepare for inspections.

Summary: This SOP shows EMEA's internal procedures for inspections triggered by applications for a central marketing authorisation, e.g. for biotechnological products.


If you are interested in internal procedures in pharmaceutical companies because you are expecting an official inspection, we recommend you to attend our event

How to pass EU and FDA inspections

During one of the 3 workshops, the participants will work out a thorough inspection preparation.

Author: Sven Pommeranz



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