EC guide to GMP, Ch 6 (Quality Control)

Introduction

QC is a fundamental part of the Pharmaceutical Quality Management System and still forms an empirical assessment of the products conformity to a registered specification (either at release or throughout shelf life).

Despite the pharmaceutical industries continued reliance on QC the EU GMP chapter is succinct and most of the detail is provided in the ICH guidances.

The revision puts emphasis on the management of OOS which drives home the need for Health Authority notification in certain scenarios.

Analytical transfer also receives some more attention although again the detail is greater in the ICH text.

Some points of interest:

  • Significant negative trends….are you comfortable with what ‘significant’ and ‘trends’ means for your products?  Do you have any experiences or comments to share when your view of this topic hasn’t matched an inspectors opinion?
  • Specific method requirements for methods suggest using other EMA guidance.  Have you got any experience you can share on this?

How can you help your fellow members?

  • We all work within different PQS so with this in mind, how does your PQS account for these important topics?  Could the EU guidance benefit from your experience?  I would say yes!
  • Does the guidance go far enough? How do you think this guidance fits in with existing guidance or planned updates to other chapters?
  • This ‘guidance’ will soon need to be implemented and inspected.  Can you suggest revisions to the draft before this happens?  This is your opportunity.

To open the consultation on the revised chapter, please click HERE

How do you comment?

Simply add comments in the comment field of this page or email me on advocacy@pqg.org

Please make it clear which part of the text you are referring to (i.e. chapter heading) and provide as much information as possible to add maximum value.

In the case of this delegated act the specific areas for comment are highlighted in the document.

When should you comment by?

This consultation is now closed