Quality assurance of aseptic preparation services

Updating QAAPS

Over the next year, a key priority for RPS and NHS Pharmaceutical Quality Assurance Committee is to update the Quality Assurance of Aseptic Preparation Services (QAAPS) Standards to its 6th edition, to be published in summer 2026.

There have been major changes to technical services since 2016, when the current edition was written, including:

• Updated GMP Annex 1
• New guidance replacing EL(97)52
• iQAAPS
• Supervision legislation
• NHS aseptic transformation programme
• New therapies
• Brexit
• Devolved nations NHS strategies.

Only Part A of the new 6th edition will be updated. Working groups formed of technical services and clinical and regulatory expertise will review each chapter, with a lead author editing the final edition.

QAAPS lead author

Lead Author for the QAAPS update will be Robert Lowe, FRPharmS, a director of pharmaceutical quality assurance for specialist pharmacy services in the NHS East of England, with more than 30 years of experience in pharmacy production, quality assurance and regulation.

Robert is a Fellow, has chaired and vice-chaired the NHS Pharmaceutical Quality Assurance Committee and served on expert advisory groups to the Commission on Human Medicines and the British Pharmacopoeia Commission. He has led audits of NHS pharmacy manufacturing facilities and commercial licensed manufacturers supplying hospital pharmacies, authored MHRA-ratified national guidance and contributed to key reference works on parenteral drug delivery.

His appointment as lead author for the updated Quality Assurance of Aseptic Preparation Services standards reflects his commitment to advancing safe, effective medicines preparation across the NHS.

Thank you

The RPS and NHS Pharmaceutical Quality Assurance Committee would like to thank all applicants who applied to contribute to the next edition of the Quality Assurance of Aseptic Preparation Services (QAAPS) Standards 6th edition.

Overall, we had 150 applications to all positions, and were astounded by the number and calibre of applications.

Each applicant is a true credit to the profession, and we are delighted to announce that those below have been selected to each of the working groups.

Short-life working groups updating the Quality Assurance of Aseptic Preparation Services (QAPPS) Standards

Standards – Part A

Quality Assurance of Aseptic Preparations Services: Standards (5th edition) is available to download.

A Standards Handbook is available in print.

Standards Handbook – Part A and Part B

Quality Assurance of Aseptic Preparation Services: Standards Handbook is available in print.

This is formatted into two parts: Part A – Standards (contained in the chapters) and Part B – Support Resources.

Part B is only accessible as part of the Standards Handbook and is an aid for implementation of the standards. The support resources will help with understanding the complexities of various topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning.

Acknowledgements

RPS and the NHS Pharmaceutical Quality Assurance Committee are grateful to the editor, Dr Alison M. Beaney, and to the individuals and organisations who have provided contributions and comment for the 5th edition of Quality Assurance of Aseptic Preparation Services: Standards