Good Manufacturing Practice
10 results
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Computer Systems Validation
15 December 2025Computer systems used in medicines preparation and manufacturing should be validated
Detecting HEPA filter leaks using dispersed oil particle aerosols
18 November 2025A protocol for quality control laboratories providing a HEPA filter testing service using dispersed oil particulate (DOP) aerosols
Validation of quality control analytical methods
18 November 2025Guidance for quality control laboratories providing analytical testing services
Validation master plans
18 November 2025A validation master plan summarises all planned validation activities in a medicines preparation or manufacturing unit.
Integrity of syringes for aseptically made medicines
17 November 2025Syringe and cap combinations used as final containers for aseptically made medicines should prevent ingress of microorganisms during storage.
Aseptic transfer processes using sporicides
10 November 2025Use of sporicides is an essential step in ensuring effective decontamination of materials being transferred into pharmacy aseptic units
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.
Repacking and over-labelling small batches of medicines
4 January 2023Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP
Design, Build and Maintenance of Pharmacy Aseptic Units (Yellow Cover)
3 November 2021Originally published in 2010, information in this yellow cover document remains useful