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

Change management in technical services

20 February 2024An SPS Quality Assurance (QA) bite size learning event on the change control process.

Investigating deviations and establishing root causes

31 January 2024An SPS Quality Assurance (QA) bite size learning event on how to conduct and write an investigation report.

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.

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
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