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A Guide to Quality Control Chemical Testing of Aseptically Prepared Products

2 July 2021This document covers laboratory chemical analysis of aseptically prepared products. The reasons for analysis are outlined in Section 2 of this document

Aseptic services

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

About SPS Cytotoxic Drug and Biopharmaceutical Stability monographs and advice

24 August 2020Validated stability data ensures products compounded by cytotoxic reconstitution processes within aseptic units are safe for patients

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.

Making best use of restricted aseptic compounding capacity

18 September 2018The NHS is experiencing considerable challenges regarding the supply of aseptically prepared injectable medicines. This communication from NPSG advises all NHS customers of commercial aseptic…

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.