Good Manufacturing Practice
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Deviation management in NHS aseptic units
15 June 2026Effective deviation management helps identify, investigate, and resolve unexpected events that could affect product quality, compliance, or patient safety.
Change management in NHS aseptic units
15 June 2026All changes in pharmacy aseptic service units must be formally controlled, assessed and reviewed to ensure product quality and patient safety.
Gowning in aseptic services
29 April 2026A short video about gowning in pharmacy aseptic services.
Design, build and maintenance of pharmacy aseptic units
7 January 2026Careful planning ensures that new or refurbished aseptic units will meet current standards and promote consistent, efficient and safe practice.
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