Service advice and planning
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Exporting ATMP starting materials
11 February 2026Regulatory export requirements for hospitals procuring (harvesting) patient’s own cells/tissues for use as starting materials in the manufacture of ATMPs.
Managing out of specification ATMPs
11 February 2026This document clarifies the regulatory expectation regarding OOS ATMPs and advises hospitals on governance in the event of an OOS ATMP being offered for use.
Performing preparation risk assessments for ATMPs
11 February 2026Preparation risk assessment tools for cell and tissue-based Advanced Therapy Medicinal Products (ATMPs) and in-vivo gene therapies.
Pharmacy technicians working under Patient Group Directions
5 February 2026Useful resources and further information for pharmacy technicians working under PGDs
Use of PGDs by trainee registered healthcare professionals
5 January 2026Advice on the use of Patient Group Directions by registered healthcare professionals who are undertaking training and/or competency assessment
Validation master plans
18 November 2025A validation master plan summarises all planned validation activities in a medicines preparation or manufacturing unit.
Registration of Quality Controllers: Medical Gas Pipeline Systems
18 November 2025Quality controllers who test NHS medical gas pipelines must be suitably trained and experienced
Radiopharmaceuticals: advice for chief pharmacists
18 November 2025The safe use of radiopharmaceuticals falls within the remit of chief pharmacists.
Supervision of aseptic preparation under Section 10 exemption
17 November 2025The section 10 exemption from the Medicines Act permits aseptic preparation of medicines under the supervision of a pharmacist.
Understanding iQAAPS
6 November 2025An introduction to the iQAAPS system, with information on how to access the system, find training resources and support contacts