Comparative Analysis: The 2024 QP Code of Practice


The revised April 2024 "QP Code of Practice" document introduces significant changes and updates compared to the November 2018 version.

Below is an irreverent summary of the nature of the changes in the 2024 version, an editorial view, and very much a personal view. If like me you want to undertake your own forensic review highlighting some of the more nuanced updates you can find the new file, here, and the old version from 2018 here. Because that’s what we tend to do.

1. Don’t mention the EU!

  • This is most starkly illustrated by the wholesale banishment of EU legislation references. Thou shall refer to UK licencing authorities. As a result section 2 of the 2018 version (Regulatory basis for the Qualified person) is with us no more. Similarly, references to EU directives are no more.

  • Annex 16 is only mentioned twice! And then it is the UK’s resolute Annex 16 of the MHRAs Orange Guide, Not that pesky EU Annex 16 which is a different thing altogether…

  • Speaking of MHRA, its prominence drops significantly, to be replaced by the much less specific and flexible “Licencing Authority”. There is only one mention of the MHRA when not referencing the MHRA Orange Guide.

2. Modernisation

  • Other than Brexit, several trends have impacted the QP and the refresh over 6 years reflects changes seen more broadly in the pharmaceutical industry and provides clarification to the original guidance. These clarifications include:

    • QPs responsibilities do not decline with an increase in the prevalence of home working, flexible or part time working.

    • Ensure that travel restrictions (such as COVID19 for example) do not impact your role.

    • There is a specific paragraph added to ensure remote QP certification is captured within the PQS. All activities that contract QPs undertake should be governed in the quality agreement with the contact QP.

    • Like with every bit of modern guidance ICH Q9 gets a shout out. Disappointingly the QP Notebook is not yet referenced.

3. More specificity in role and duties

  • In three sections in particular (Introduction, Practical Duties of a Qualified Person and Performance of Duties and Regulatory Compliance there is much expanded discussion on the QP's legal duty to ensure compliance with national laws, the requirements of Marketing Authorisations, and Good Manufacturing Practice (GMP). This is combined with increasing the importance of oversight and reliance on the PQS.

  • There is an increased emphasis on the role of QP or Quality agreements, particularly for complex activities.

  • In section 6.3, an important addition is the requirement to inform senior management of the legal role and responsibilities of a QP.

  • In several sections the need to comply with the local legislation of the market into which the QP is certifying product is given greater emphasis.

  • The section on disciplinary procedures has a interesting couple of additions to highlight that ignorance is not a viable excuse in our trade.

    • If it were found that a QP had intentionally or unintentionally certified a batch as fit for sale or supply without ensuring that the relevant tests and checks had been performed or was otherwise not in compliance with either GMP or the Marketing Authorisation / PSF, this would be considered by both the appropriate Professional Body and the Licensing Authorities as a matter of professional misconduct

  • The slightly tweaked section on Continued Professional Development (CPD): Stresses the importance of ongoing professional development in response to evolving technologies and regulatory landscapes.

4. Little bits and pieces

  • Finally the document is not without its little quirks.

    • Section 9.3 references section 10.1 when it should reference section 9.1 - oh the scandal! Its a subtle reminder that the old section 2 is no more.

    • Switzerland now has QPs! It just seems quirky that this gets a special shout out to me.

Overall, the revision is not a wholesale rewrite and its modest changes reflect the evolving regulatory environment, particularly in response to Brexit, and the need for QPs to adapt to new legal frameworks, technological advancements, and changing workplace norms.

Disclaimer

This document is not a legal document not should it be interpreted in any fashion as a guide. This is a set of notes compiled as part of a personal CPD program.  It is not complete or authoritative. I hope it gives you some value.

This is a personal effort and is not affiliated with my current role or employer.

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. If you use it to train someone else, fantastic, but give the QP Notebook a plug. Thanks