All our advice relating to aseptic preparation and the safe provision of aseptic services.

Guidance for Accountable Pharmacists on submission of Quality Indicators (QI) for NHS Section 10 aseptic preparation activities using the iQAAPS system.
The stability of several aseptically compounded ready to administer presentations of monoclonal antibody products and other biopharmaceuticals is presented.

Aseptic services

Temperature controlled storage of medicines

22 March 2024An SPS Quality Assurance (QA) bite size learning event on controlling the temperature of medicines in storage.

Responding to Annex 1 EU GMP changes

10 August 2023A summary of the August 2022 changes to Annex 1 EU GMP, including responses from the MHRA, and QA committee guidance

Managing defective medicines

19 June 2023An overview of what defective medicines are and how they should be reported by NHS personnel.

Dealing with out of specification (OOS) results: Part 2

9 May 2023This webinar builds on the principles described in Part 1 of this series and describes how to conduct a thorough and systematic microbiological investigation.

Accredited training for pharmacy staff within technical services

17 March 2023Pharmacy staff involved in the preparation of aseptically-prepared products should be suitably trained and accredited to assure a safe service

Dealing with out of specification (OOS) results: Part 1

20 January 2023This webinar will explore the approach to managing out of specification environmental monitoring results in pharmacy aseptic units

Assurance of aseptic preparation of medicines

13 January 2023Updated guidance from NHSE to reflect governance and visibility of the assurance and audit of unlicensed aseptic preparation

Understanding iQAAPS

13 January 2023An introduction to the iQAAPS system, with information on how to access the system, find training resources and support contacts

Choosing an injectable medicine for intrathecal administration

11 August 2022The intrathecal route is a high risk route of administration. It is essential to consider the properties of the medicinal product when assessing the risk
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