EMA Proposes Updated GMP Guidance for ATMPs – Key Points to Know

EMA Proposes GMP Guideline Updates for ATMP – Important Points to Know

The European Medicines Agency (EMA) has just published a draft update to Part IV of the Good Manufacturing Practice (GMP) regulations – specifically for Advanced Therapy Medicinal Products (ATMP). The objective is to clarify and make more consistent the requirements compared to the current version, which no longer keeps pace with technical advances and the latest standards within GMP.

General introduction

The draft focuses on adjusting the core principles of GMP applied to ATMP, ensuring compatibility with modern manufacturing practices while maintaining high standards of quality and safety. This is an effort to create a clear, consistent legal framework for businesses and manufacturing facilities in the context of rapidly developing ATMP technology.

Background and reasons for revision

The current Part IV was issued in 2017, separated from other parts in the GMP code of Volume 4, but has not been updated since Annex 1 on sterile products was heavily revised in 2023. The lack of connection between Part IV and new content in Annex 1 creates technical guidance gaps, especially in areas such as Quality Risk Management (QRM), Contamination Control Strategy (CCS), modern manufacturing technology and barrier systems.

Some main contents of the proposal

Harmonization with Annex 1

The draft updates Part IV to align with sterile manufacturing requirements that have been revised in Annex 1, creating a foundation for applying stricter and more consistent aseptic control standards in ATMP manufacturing.

Integration of QRM and PQS frameworks according to ICH Q9 & Q10

EMA proposes incorporating quality risk management principles (ICH Q9) and pharmaceutical quality system (ICH Q10) to enhance control throughout the product lifecycle, helping manufacturing facilities proactively identify, assess and mitigate risks.

Contamination Control Strategy (CCS) Advisor

The new section will provide specific guidance on CCS – a key element to prevent contamination in ATMP manufacturing, especially in the context of processes that are often highly manual and small-batch, personalized.

Embracing advanced manufacturing technologies

The guidance expands to encourage adoption of new technologies and solutions such as: advanced automation systems; closed single-use systems; and rapid microbiological testing methods. The goal is to enhance efficiency, repeatability and safety of processes.

• Optimize workflows and reduce manual operations.
• Reduce cross-contamination risk through closed systems and single-use materials.
• Shorten test result turnaround time, supporting faster batch release decisions.

Updated guidance on cleanrooms and barrier systems

The draft clarifies how to classify cleanrooms, control and operate barrier systems such as isolators and RABS, while still allowing flexibility in using biosafety cabinets – suitable for the characteristics of many manual steps in ATMP manufacturing.

• Emphasize personnel flow – material flow design to reduce contamination risk.
• Guide environmental monitoring, cleaning – decontamination according to risk-based strategy.
• Encourage adoption of barrier systems to reduce direct contact with the manufacturing environment.

Legal updates on human-derived raw materials

The draft introduces clearer requirements for quality and safety of human-derived materials, ensuring compliance with current regulations while creating transparency for manufacturers in the evaluation and supply chain management process.

Implementation roadmap

The draft (Concept Paper) has been published and opened for public comment period from May 08 to July 08, 2025. According to the plan, the full draft guidance is expected to be released in September 2026 and officially adopted in March 2027.

Community feedback

The International Society for Stem Cell Research (ISSCR) supports the update proposal, emphasizing the need for clarity, eliminating contradictions and integrating guidance on new technologies. ISSCR also suggests considering merging some content into the main part of EudraLex Volume 4 to increase consistency for ATMP developers.

Conclusion & recommendations

The update of Part IV GMP for ATMP is an important step in integrating the latest quality standards and modern technology into advanced biological pharmaceutical manufacturing processes. Notable highlights include:

• Compliance with the latest sterile manufacturing standards from Annex 1.
• Integration of modern risk management framework and quality system (ICH Q9/Q10).
• Embracing automation, single-use systems and rapid microbiological testing techniques.
• Clarifying guidance on operating contamination barrier systems in manufacturing.
• Updating legal framework for human-derived raw materials.

Advice for stakeholders: If you have not participated in the comment period (ending July 08, 2025), please monitor the next milestones and prepare plans to update internal quality systems to be ready to apply when the official guidance is adopted.

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