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Aseptic services

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Guidance for the Validation of Pharmaceutical Quality Control Analytical Methods 1st Edition (Yellow Cover)

24 May 2010This document is intended to provide a framework for NHS Pharmaceutical Quality Control laboratories to enable a consistent and robust approach to analytical method validation.…

Quality Assurance of Radiopharmaceuticals Edition 4 2012 (Yellow Cover)

17 April 2012The purpose of this document is to advise all NHS and academic units that manufacture radiopharmaceuticals, and their auditors, on recommended minimum standards for Quality…
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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

Validation Master Plan 1st edition (Yellow Cover)

25 May 2010The Validation Master Plan (VMP) is a summary of the planned validation activities. It lists those activities and essential documents which will be generated and…

Introduction to the aseptics stability tool

17 February 2025An SPS Quality Assurance (QA) bite size learning event that introduced the aseptics stability tool.

Internal audit in aseptic services

3 March 2025An SPS Quality Assurance (QA) bite size learning event on internal audit in aseptic services.

Baclofen: informing intrathecal risk assessment

7 May 2025Baclofen products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Clonidine: informing intrathecal risk assessment

16 May 2025Clonidine products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Worksheet design and aseptic processing control

23 April 2025A bite size learning event on worksheet design and processing control in pharmacy aseptic services. 23 May 2025.

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