Standards knowledge framework · Medical devices, pharma & cosmetics
GMP
Good manufacturing practice for pharmaceuticals, food and cosmetics by sector.
Applicability
For medical devices, pharma and cosmetics, requiring tight quality, hygiene and batch-record controls.
Core focus areas
- Document, change and training control
- Hygiene, production conditions and process validation
- Traceability, complaints and nonconforming-product handling
Common audit watchpoints
- Batch records are incomplete or changes are not traceable
- Training is not tied to job roles
- Hygiene and environmental controls lack trend records
Related documents
Applicable SOPs, forms and solution packs will be curated here by standard. Selected packs may become Premium once the library is mature.
Open document libraryThis is practical preparation guidance, not a replacement for official criteria, standard-owner guidance or legal advice.