Frequently Asked Questions by QPs - the EQPA Discussion Forum
(Article based on the presentation by David Cockburn, EQPA Board, at bers the QP Forum 2020)
The European QP Association (EQPA) was founded in July 2006 by the European Compliance Academy's (ECA) Advisory Board Members. With this unique association the ECA wants to provide QPs in Europe with a platform allowing them to exchange their experience, discuss the latest regulatory requirements, to identify and ad dress difficulties and challenges and to support a harmonised European approach. In the meantime EQPA represents more than 3.500 members. One of the services offered by EQPA is the discussion forum in the members area of the website (www.qp-association.eu).
The discussion forum gives members the opportunity to address QP-related questions. And it is frequently used. Every week questions come in which are normally answered within a few hours by the members of the Board or other QPs.
In the past three years, the top 5 topics were:
1. Serialisation
2. General QP Certification issues
3. UK exit from EU ("Brexit")
4. Shelf life/Expiry date
5. API Audit and QP Declaration
Typical posts on serialisation for example cover questions on the clarification of responsibilities when the unique identifier is affix by a separate contractor or the responsibility of QPs with respect to confirmation of data upload. Whereas questions on general QP certification issues refer to certification/ release under quarantine or "QP discretion". During the pandemic with its travel restrictions and increased home office remote certification was another hot topic. Not to forget the UK exit from the EU ("Brexit") with its am biguities and uncertainties.
Most of the questions are answered clearly and straight away. However some posts generate longer discussions. Examples of some of these posts are questions like:
- "Is it possible to certify a batch when an input raw material has not been released for use?"
- "API site deleted from MA after bulk batch manufactured but before it is packaged. Can QP certify the finished batch?"
- "Can local Inspector insist on providing all supplier audit re ports in full to MAH?"
Recommendation
Berlin, Germany4/5 December 2024
Root Cause Analysis
And some post are really interesting. One QP had to deal with a known concern about an analytical method for a release-critical test and the Quality Control unit proposed to vary the registered method. However Management was unwilling to file the variation and put the QP under pressure to certify the batches. So what should the QP do? Use "QP discretion"? Refuse certification? Or even inform the competent authority? The advice given was to in form the company that the QP is minded to involve the supervisory authority and also ask the company to seek an independent expert opinion. If shortage is imminent, MAH should inform authorities of affected markets.
In another issue, an importer refused to provide the QP with data logger read-outs from shipments. The importer stated that they will notify the QP only if an excursion has occurred (sample ship ment is separate from main shipment). Here there is no right or wrong and the QP needs to decide what is needed for decision making and what can be delegated (and how).
In one of the latest posts, the requirements for so called QP-to-QP Agreements were questioned. In the answers it was pointed out that a QP-to-QP Agreement is not a specific requirement in EU GMP. Contractual arrangements should be set up between MIAHs (companies) and must refer to the respective QP arrangements. QPs should of course be consulted on those aspects before the agreement is made. However QP-to-QP Agreements are not forbid den and sometimes integrated in the overall framework of the contract(s). The IMP working group of the EQPA for example has developed a generic template that IMP QPs can download from the EQPA website.
Recommendation
22/23 January 2025
HPLC Data Integrity - Live Online Training
So to conclude, the EQPA Discussion Forum can be very useful for QPs and EQPA members are very much encouraged to participate. If you are not a QP or member of EQPA, you may be interested in ECA's GMP Discussion Forum as an alternative way of discussing GMP-related questions with a large audience. It can be found in the members area of the ECA website:
https://www.gmp-compliance.org/members-area.
This article is taken from the EQPA Newsletter. All other articles in the EQPA Newsletter are only available to EQPA members.
About the Author
Wolfgang Schmitt
... is Vice President at CONCEPT HEIDELBERG and organises and conducts courses and conferences on behalf of the ECA Academy
in the areas QA and GMP.
