Definition
GMP (Good Manufacturing Practice) is a system of regulations, codes, and guidelines ensuring pharmaceutical products are consistently produced and controlled according to quality standards appropriate for their intended use. The ācā in cGMP emphasizes manufacturers must use current, up-to-date methods.
How GMP Works
GMP regulations establish minimum requirements for methods, facilities, and controls used in manufacturing. Compliance is verified through FDA inspections and internal quality systems.
GMP Requirements
| Area | Requirements |
|---|---|
| Facilities | Clean, appropriate design, maintained |
| Equipment | Qualified, calibrated, validated |
| Personnel | Trained, qualified, adequate staffing |
| Documentation | Complete, accurate, traceable |
| Materials | Tested, approved, properly stored |
| Production | Validated processes, controlled conditions |
| Quality Control | Testing, release procedures, stability |
Key GMP Principles
- Written Procedures: All processes documented
- Validation: Processes proven to work consistently
- Training: Personnel qualified for their roles
- Record Keeping: Complete batch history
- Traceability: Materials tracked through production
- Change Control: Modifications properly evaluated
Why BD Teams Track GMP
For business development professionals, GMP compliance affects partnerships:
- Deal Implication: GMP issues can delay product approvals and supply
- Due Diligence Focus: Review facility inspection history and quality systems
- Opportunity Signal: Companies with strong GMP track records are preferred partners