Revised EMA Paper Specifies Requirements on Preparation, Conduct and Follow-Up of Official Inspections

In connection with the "Compilation of Community Procedures on Inspections and Exchange of Information", which is a compilation of EU-wide operating procedures for the registration and supervisory authorities (see also our GMP News from 2001), the EMA revised the document "Conduct of Inspections of Pharmaceutical Manufacturers". It deals with the authorities' approach to inspecting pharmaceutical manufacturers and importers and is therefore also of great interest to the pharmaceutical industry itself, but also to manufacturers of investigational medicinal products and active pharmaceutical ingredients, who are addressed as well.

The document is an updated version of the document with the same title from the year 2006. It is the aim of this update to adapt the text to the state of the art (e. g. risk-based inspection approach). The compilation is divided into 9 chapters and includes 3 annexes:

1. Introduction
2. General Considerations on Inspections
3. Inspections Planning and Preparation
4. Inspection Steps
5. Final Meeting
6. Inspection Report
7. Inspection Frequency
8. Quality Management of the Inspector's Activity
9. Glossary of Terms
Annex 1 Conduct of Production Related Inspections
Annex 2 Conduct of Inspections for Investigational Medicinal Products for Human Use
Annex 3 Conduct of Inspections of Active Substance Manufacturers

What is interesting is the relative level of details in this document. So, especially chapter 3 (Inspections Planning and Preparation) mentions, among other things, concrete documents inspectors may want to have a look at when preparing an inspection. These include e.g. a site master file or a review of the recalls.

Then, chapter 4 gives recommendations on how inspectors should conduct the inspection on site. This includes the opening meeting up to the areas and documents to be inspected. The procedure for holding the final meeting is also defined (chapter 5).

Especially the annexes go into more detail again - always with reference to an adjustment to the dossier for the marketing authorisation (if there is one). This concerns product-specific inspections (annex 1), but also inspections related to the manufacture of investigational medicinal products (annex 2) or to the manufacture of active substances.

On balance, one can say that, in the sense of a changed perspective, the document is certainly useful for the pharmaceutical industry, for manufacturers of investigational medicinal products or of active pharmaceutical ingredients to prepare themselves for an official inspection.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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