GMP covers the whole manufacturing operation: premises and equipment, personnel, documentation, production, quality control, and packaging and labeling. In the US, drug GMP is set out in 21 CFR Parts 210 and 211, and device requirements sit in the Quality Management System Regulation (21 CFR Part 820). In the EU, the rules are in the EU GMP guidelines (EudraLex Volume 4). Cosmetics manufacturers commonly follow ISO 22716, and MoCRA requires FDA to set cosmetic GMP regulations, which are still pending.
Why it matters for labeling
Labels and packaging are part of the product, so labeling operations fall under GMP: how labeling is approved, printed, issued and checked, and how mix-ups are prevented. The records of these steps have to be accurate and retrievable, and any computerized system used for them is subject to validation and audit trail expectations. GMP is the manufacturing-specific frame; GxP covers the same idea across all the "good practice" areas.
Common mistakes
- Treating labeling as outside the quality system, with approvals that live in email
- No control over obsolete labeling, so an old version reaches a reprint
- Using unvalidated software to make or support labeling decisions
- Assuming GMP rules are identical across markets