GMP

Good Manufacturing Practice (GMP) is a system that ensures products are consistently produced and controlled according to quality standards. For medical devices, GMP covers all aspects of manufacturing from raw materials, facilities, and equipment to training and personal hygiene of staff.

GMP frameworks by region:

USA - FDA Quality System Regulation (QSR):
- 21 CFR Part 820
- Often called "cGMP" (current GMP)
- Design controls required
- Recently updated to align with ISO 13485

EU - EU MDR Requirements:
- ISO 13485 certification typically required
- Notified Body audits manufacturing
- Part of conformity assessment

Other major frameworks:
- Brazil (ANVISA): RDC 665/2022, RDC 16/2013
- Japan (PMDA): MHLW Ordinance No. 169
- China (NMPA): Medical Device GMP
- Mexico (COFEPRIS): NOM-241-SSA1-2012

Key GMP elements:
1. Quality Management System - Documented procedures
2. Design Controls - From concept to production
3. Production Controls - Manufacturing processes
4. Corrective/Preventive Actions (CAPA) - Problem solving
5. Document Control - Procedures and records
6. Training - Personnel qualifications
7. Facility Controls - Clean environments
8. Equipment - Calibration and maintenance
9. Purchasing Controls - Supplier qualification
10. Traceability - Component to finished device

GMP Certificate:
Some countries require a GMP certificate for device registration. This may come from:
- National authority inspection
- Notified Body audit
- Recognized third-party audit