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Supply of aseptically Prepared Doses of IMPs Across Legal Boundaries Version 2 October 2019
11 November 2019
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This document has been developed by the NHS Quality Assurance Committee and National Pharmacy Clinical Trials Advisory Group with input provided by the MHRA Clinical…
Registration required
Ganciclovir: Cytotoxic Drug Stability Monograph
13 November 2020
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Stability information is essential for the safe aseptic preparation of Ganciclovir
Submitting iQAAPS Quality Indicators (QIs)
13 April 2023
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Guidance for Accountable Pharmacists on submission of Quality Indicators (QI) for NHS Section 10 aseptic preparation activities using the iQAAPS system.
Computer Systems Validation (Yellow Cover)
29 July 2013
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This document is based on the North West Guidance Document on Computer Systems Validation. The Orange Guide 2002 Annex 11 introduced a requirement for validation…
Repacking and over-labelling small batches of medicines
1 October 2020
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Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP
Guidance on Definition of Supervision under Section 10 Aseptic Preparation Activities, 3rd Edition, Sep 2019 (Yellow Cover)
3 September 2019
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The NHS Aseptic Services Accreditation Working Group, working closely with the South West Product Approval Accreditation Programme have developed and published a definition of Supervision…
Risk Associated with the Outsourcing of the Aseptic Compounding of Parenteral Nutrition (Yellow Cover)
16 December 2016
·
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…
Registration required
Dacarbazine: Cytotoxic Drug Stability Monograph
24 August 2020
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Stability information is essential for the safe aseptic preparation of dacarbazine
Registration required
Docetaxel: Cytotoxic Drug Stability Monograph
25 August 2020
·
Stability information is essential for the safe aseptic preparation of docetaxel
Registration required
Mitomycin: Cytotoxic Drug Stability Monograph
25 August 2020
·
Stability information is essential for the safe aseptic preparation of mitomycin
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