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

Management review and KPIs in pharmacy technical services

20 November 2024An SPS Quality Assurance (QA) bite size learning event on quality management review and key performance indicators (KPIs) in pharmacy technical services.

Quality assurance for aseptic services videos

11 October 2024A series of short videos about quality assurance in aseptic services

Dealing with OOS Microbiology Results in Pharmacy Aseptic Units (Part 2)

18 September 2024An SPS Quality Assurance (QA) bite size learning event on managing out of specification microbiological environmental monitoring results in aseptic units.

Process risk assessments for a Contamination Control Strategy

19 March 2024Performing a Process Risk Assessment (PRA) to inform contamination control strategy for manufacturing processes within NHS units.

Understanding contamination control in pharmacy aseptic services

19 March 2024A co-ordinated approach to preventing microbial contamination ensures that aseptically prepared medicines are safe for patients.

Preparing eye drops in unlicensed aseptic units

17 October 2023Circumstances and potential risks should be considered before preparing eye drops in NHS aseptic units working under Section 10 exemption.

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.

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

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
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