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Aseptic services

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Risk Associated with the Outsourcing of the Aseptic Compounding of Parenteral Nutrition (Yellow Cover)

16 December 2016The purpose of this document is to give guidance to those outsourcing PN compounding on the risks in the outsourcing and supply process and to…
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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

Repacking and over-labelling small batches of medicines

1 October 2020Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP

Quality assurance for aseptic services videos

11 October 2024A series of short videos about quality assurance in aseptic services

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…

Process risk assessments for a Contamination Control Strategy

19 March 2024Performing a Process Risk Assessment (PRA) to inform contamination control strategy for manufacturing processes within NHS units.

Preventing harm from incorrect vinca alkaloid administration

13 June 2025Vinca alkaloids can cause paralysis and death if given by the wrong route. Understand how to reduce the risk to patients.

Preparing for audits and inspections of aseptic services

10 March 2025Careful planning ensures maximum benefit for both the auditee and auditor

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.

Phenol: informing intrathecal risk assessment

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