EudraLex Vol. 4 Part IV: One for all?

Biotechnologically produced drugs are booming

Advanced therapy medicinal products (ATMPs) are at the forefront of regulatory developments, including good manufacturing practice requirements. A still very young ATMP GMP guide is going down paths that have not yet existed in the GMP universe.

GMP regulations – EudraLex

Firstly, the 90-page guide is largely independent of other GMP regulations. This is very surprising, as the annexes of the GMP Guide in particular have almost always been applied to all other pharmaceutical situations. However, there are hardly any references to the classic annexes in the ATMP guidelines.

ATMP Guide

Secondly, the new ATMP Guide promotes a more risk-based approach in the pharmaceutical quality system. This may not sound new in principle, but in terms of conventional GMP requirements, it certainly is. If the Guide is interpreted literally, there are some degrees of freedom that historically did not exist for the manufacture of medicinal products or that were often not granted in practice despite ICHQ9 / GMP Guideline Part 3 – depending on the supervisory authority.

GMP special regulations

Thirdly, there are some special GMP regulations for ATMPs, such as decentralized release or concessions to process validation requirements. It is worth studying the text carefully, as much of it sounds similar to the familiar GMP regulations, but on closer inspection the details are different. And it adds up(!).

Finally, the ATMPs GMP guideline also sets out its own rules for investigational medicinal products. No wonder, because the IMP GMP Guide, which is also very new and is currently placed under EUDRALEX Volume 4 Annex 13, does not apply to I-ATMPs. In clinical development, this also means that it pays to take a closer look.

Conclusion

The latest ATMP guideline is not only a helpful tool for clarifying the regulatory expectations of GMP. But it also takes an important step away from a less rigid application of fixed and sometimes excessive specification lists (GMP overkill), towards an adapted GMP approach – namely quality assurance based on technical knowledge and compliance awareness.

It remains to be seen whether the European way of thinking will prove to be compatible with the requirements of other countries, or whether this fundamentally sensible EU approach will simply have to serve an additional compliance world that will not exist anywhere else in the world.

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Dipl. Ing. Wolfgang Rudloff

Vita

• 30 Jahre Erfahrung in der pharamzeutischen Industrie

Expertise:

• Geprüfter Sachverständiger für Reinraumtechnik und GMP-Management
• Lead Auditor und Gutachter

Stationen:

• Technischer Leiter
• COO / Gesamt-Herstellungsleiter
• Remidiation-Manager
• Projektleiter Neubau/GMP-Upgrade
• Management-GMP-Beratung
• Fachautor, GMP-Trainer, Mediator