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Aseptic services

All our advice relating to aseptic preparation and the safe provision of aseptic services.
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Management of Particulate Contamination of Aseptically Prepared Products - NHS Pharmaceutical Quality Assurance Committee Guidance Note

24 November 2020Management of Particulate Contamination of Aseptically Prepared Products – NHS Pharmaceutical Quality Assurance Committee Guidance Note

Repacking and over-labelling small batches of medicines

1 October 2020Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP

Supply of aseptically Prepared Doses of IMPs Across Legal Boundaries Version 2 October 2019

11 November 2019This document has been developed by the NHS Quality Assurance Committee and National Pharmacy Clinical Trials Advisory Group with input provided by the MHRA Clinical…

Guidance on Definition of Supervision under Section 10 Aseptic Preparation Activities, 3rd Edition, Sep 2019 (Yellow Cover)

3 September 2019The NHS Aseptic Services Accreditation Working Group, working closely with the South West Product Approval Accreditation Programme have developed and published a definition of Supervision…

Measurement of HEPA filter performance using the dispersed oil particle aerosol test for leak detection in filter installations ed 3

20 December 2018This test protocol is supplementary to Quality Assurance of Aseptic Preparation Services, Fifth edition, Edited by Alison M Beaney, Pharmaceutical Press, 2016.

Guidance on Handling of Injectable Cytotoxic Drugs in Clinical Areas in in NHS Hospitals in the UK (Yellow Cover) Edition 1 July 2018

31 July 2018Intended audience: This document is intended as a reference and source of information to the following audiences: Nursing staff who handle cytotoxic chemotherapy (Oncology /…

Standard Protocol for Deriving and Assessment of Stability - Part 5 Sterile Products

1 June 2017This protocol applies to small molecule products of all presentations, manufactured from non-sterile starting materials and sterilised in their final container.

A Standard Protocol for Derivation and Assessment of Stability Part 4 – Parenteral Nutrition

1 June 2017To support NHS compounding units and purchasers to derive and assess stability data for pharmaceutical products (Specials and extemporaneously compounded).

Standard Protocol for Deriving and Assessment of Stability - Part 2: Aseptic Preparations (Biopharmaceuticals)

6 March 2017Stability of the protein structure is an important feature in preserving the safety and efficacy of biopharmaceuticals.