GMP Annex 16 (QP)
Introduction
Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch release, is the subject of a concept paper by the European Medicines Agency (EMA)
The annex was originally included in the GMP guide in 2002. The Qualified Person’s (QPs) within the PQG membership will appreciate there has been a tremendous period of change since the content was originally made available; with the number of years that have passed since giving no real indication of the volume of changes in that time.
However, depsite the number of changes to legislation, the resulting incremental increases in QP’s responsibilities, and the increasing number of scenarios a QP may face today; the QP’s legal responsibility to patients remains the same.
Therefore the experience of the PQG membership gained from facing the impact of legislative changes and the general evolution of the pharmaceutical industry is incredibly important in making this annex as applicable in practice as it can be.
Some points to consider:
- The EMA reflection paper on QP discretion. Can this be clarified in the Annex?
- With increasing requirements on supply chain assurance and declarations regarding API’s, how will this be incorporated in the text?
- Scenarios relevant to the industry we operate in (IMPs, generics, virtual companies etc) need to be accounted for rather than the classical model of manufacturers and contractors solely.
To open the concept paper on Annex 16 of the GMP guide (consultation) 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.
When should you comment by?
I will collate all comments and respond on behalf of the PQG members by the deadline for the consultation. With this in mind, can you provide all comments by the 27th January 2012 Thanks!
4 Responses to “GMP Annex 16 (QP)”
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[Background: now retired but former QP and had a large part in drafting the original annex 16 as a member of a regulatory authority].
Much of the Concept paper seems well founded and sensible. While section 3 2nd & 3rd paragraphs correctly say that the original Directives did not envisage the remote sites now common, it should acknowledge that this development was recognised in the original Annex 16 and indeed was the main reason for its production.
I believe that sound and up-to-date knowledge of the manufacturing site obtained through audit is essential. However for every EU/EEA importer (whether of starting materials or finished products) to perform their own audits in 3rd countries is inefficient, burdensome through repetition on the site being audited and in practice unlikley to be fully achieved. The Concept should address this. Possibilities include formal co-operation between QPs of different companies with shared interest in a site by exchanging results, use of a contract audit company with QPs, and more access to and use of the findings of inspections that are (or should be) conducted by regulatory authorities in partial substitution for their own audits, by payment of a fee.
Section 3 discussion
1. The reflection paper has raised practical problems for QPs, where IMB and MHRA have taken a different stance. QP “handshake” is almost impossible is one is allowed discretion but the other is not.
Clear guidance on QP “handshake” would be of benefit.
2. I agree that more clarity is needed of the extent of personal involvement of the QP versus reliance on quality systems and other personnel, where manufacture takes place at a site which is remote from the QP.
Phenomenal breakdown of the topic, you should write for me too!
John, Thanks for your comments, which are valuable as usual. PQG has always been concerned that it is difficult for pharma companies to audit every supplier themselves. Consequently, PQG has participated in the development of the Excipact project to use independent third party certification bodies to audit and certify excipient manufacturers to a well established GMP standard. This should, in time, help both pharma companies and excipient companies to achieve both acceptable standards, meet the audit requirements of regulators and save cost all round.
More information on Excipact is available on the PQG and Excipact websites.