Quality Assurance of Aseptic Preparation Services

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These standards for the quality assurance of aseptic preparation services are a joint initiative between the Royal Pharmaceutical Society and the NHS Pharmaceutical Quality Assurance Committee (NHS PQAC).

The standards are for unlicensed aseptic preparation in the UK. They will be used by pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services.

The Royal Pharmaceutical Society produce and host these standards as part of our library of professional standards. Earlier editions were published by the Pharmaceutical Press.

Updating QAAPS

Over the next year, a key priority for the 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 over 30 years of experience in pharmacy production, quality assurance and regulation.

Robert is a Fellow of the RPS, 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

Right Medicine (Chapters 3,4 and 6)

+ EXPAND
- Katherine O'Rourke*
- Anne Black*
- Louisa Knowles
- John Oliver
- Amy Osterloh
- Lucy Reed
- Maria Blanco-Criado
- Sean Dodington
- Pavanjit Nahal
- Jonathon Davies
- Amy Laflin
- Kaye Mcilvar
- Anne Lyttle
- Alistair Ellis-Jones
- Duncan Thain
- Satishkumar Patel.
* Chair and Co-Chair
Infrastructure and Capability (Chapters 5,7 and 9)

+ EXPAND
- Matthew Pitt*
- Nadia Rolf*
- Charlotte Ollerenshaw-Ward
- Sue Renn
- Dariusz Osowski
- Lauren Price
- Matthew Stubbs
- Angela Bolch
- Laura Morgan
- Caroline Reid
- Philip Jones
- Emma McFarlane
- Charlene Begley
- Catherine Talbot
- Oonagh Farr
- Adam Walker.
* Chair and Co-Chair
Production (Chapters 10,12,13 and 15)

+ EXPAND
- Hannah Miller*
- Matt Greening*
- Linda Musker
- Graeme Richard Willmers
- Kirsten Heukelbach
- Hélio Fazenda
- Amy Hill
- Kristine Lambert
- Kevin P. Griffiths
- Louise Mounsey
- Kyle Winn
- Fiona McGill
- Trudy Beattie
- Chelsie Marshall
- Lorna Purdy
- Helen Callaby.
* Chair and Co-Chair
Quality Control/Assurance (Chapters 8,11,14 and 16)

+ EXPAND
- Linda Hardy*
- Prof. Oweikumo Eradiri*
- Marc Lennon
- Katherine Cole
- Charlotte Monaghan
- Sarah Holliday
- Samuel Oteng-Mensah
- Lucy Delaney
- Richard Skidmore
- Mark Cox
- Matthew Phythian
- Lisa Galloway
- Anthony Crossan
- Emma Davies
- Jack Whitelaw
- David Caulfield.
* Chair and Co-Chair

Standards - Part A

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

A Standards Handbook is available in print.

DOWNLOAD PART A

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.

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Acknowledgements

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

View the acknowledgements

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