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Quality Assurance and Technical Services (QATS) Symposium 2024
16 April 2024
·
Bringing together NHS experts and regulators covering topics of quality assurance, quality control, good manufacturing practice and regulatory expectations.
Quality Assurance of Radiopharmaceuticals Edition 4 2012 (Yellow Cover)
17 April 2012
·
The purpose of this document is to advise all NHS and academic units that manufacture radiopharmaceuticals, and their auditors, on recommended minimum standards for Quality…
Repacking and over-labelling small batches of medicines
1 October 2020
·
Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP
Registration required
Responding to Annex 1 EU GMP changes
10 August 2023
·
A summary of the August 2022 changes to Annex 1 EU GMP, including responses from the MHRA, and QA committee guidance
Risk Associated with the Outsourcing of the Aseptic Compounding of Parenteral Nutrition (Yellow Cover)
16 December 2016
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The purpose of this document is to give guidance to those outsourcing PN compounding on the risks in the outsourcing and supply process and to…
Rituximab: informing intrathecal risk assessment
11 August 2022
·
Rituximab products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
Ropivacaine: informing intrathecal risk assessment
11 August 2022
·
Ropivacaine products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
Standard Protocol for Deriving and Assessment of Stability - Part 2: Aseptic Preparations (Biopharmaceuticals)
6 March 2017
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Stability of the protein structure is an important feature in preserving the safety and efficacy of biopharmaceuticals.
Standard Protocol for Deriving and Assessment of Stability - Part 5 Sterile Products
1 June 2017
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This protocol applies to small molecule products of all presentations, manufactured from non-sterile starting materials and sterilised in their final container.
Submitting iQAAPS Quality Indicators (QIs)
13 April 2023
·
Guidance for Accountable Pharmacists on submission of Quality Indicators (QI) for NHS Section 10 aseptic preparation activities using the iQAAPS system.
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