Good Manufacturing Practice
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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.
Understanding contamination control in pharmacy aseptic services
19 March 2024A co-ordinated approach to preventing microbial contamination ensures that aseptically prepared medicines are safe for patients.
Design, Build and Maintenance of Pharmacy Aseptic Units (Yellow Cover)
3 November 2021Originally published in 2010, information in this yellow cover document remains useful
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
Detecting HEPA filter leaks using dispersed oil particle aerosols
20 December 2018A protocol for quality control laboratories providing a HEPA filter testing service using dispersed oil particulate (DOP) aerosols
Aseptic transfer processes using sporicides
31 July 2015Use of sporicides is an essential step in ensuring effective decontamination of materials being transferred into pharmacy aseptic units
Computer Systems Validation (Yellow Cover)
29 July 2013This document is based on the North West Guidance Document on Computer Systems Validation. The Orange Guide 2002 Annex 11 introduced a requirement for validation…
Integrity of syringes for aseptically made medicines
29 July 2013Syringe and cap combinations used as final containers for aseptically made medicines should prevent ingress of microorganisms during storage.
Validation master plans
25 May 2010A validation master plan summarises all planned validation activities in a medicines preparation or manufacturing unit.