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Aseptic services

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Thiotepa: informing intrathecal risk assessment

11 August 2022Thiotepa products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Temperature controlled storage of medicines

24 May 2025An SPS Quality Assurance (QA) bite size learning event on storing medicines in controlled temperatures. 25 July 2025.

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…

Submitting iQAAPS Quality Indicators (QIs)

13 April 2023Guidance for Accountable Pharmacists on submission of Quality Indicators (QI) for NHS Section 10 aseptic preparation activities using the iQAAPS system.

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.

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.
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Stability resources for aseptic services 

7 February 2025Stability data supports extended shelf lives for aseptically prepared medicines

Shelf lives of aseptically prepared medicines in NRFit syringes

19 December 2024Provision of intrathecal and epidural injections in NRFit syringes may involve extrapolation of stability data from luer lock systems

Ropivacaine: informing intrathecal risk assessment

11 August 2022Ropivacaine products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Rituximab: informing intrathecal risk assessment

11 August 2022Rituximab products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration