Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)
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UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 6
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-16
- Category
- Safety & operations
- Licence
- Open Government Licence v3.0
Description
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products. Consult the original guidance for current legal and operational details.
Contents
- Manufacturing Licence applications and Inspection approach
- Pharmaceutical Quality Systems (PQS).
- Substances of human origin (SoHO) used as starting materials
- Shared facilities
- Product Release for Products with short shelf lives (POC)
- Product Release for Modular Manufacturing (MM) Products
- Product Reviews
- Reference and retention samples
- Named individuals on Manufacturing licences
- Home based manufacturing considerations
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)’ (updated 10 June 2025), reused under the Open Government Licence v3.0.
ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.
Version history
- v1.016/09/2026