This GMP Awareness training is specifically designed for excipient manufacturers and emphasizes the ExciPact guideline framework. ExciPact is the collaborative guideline developed by industry associations to harmonize GMP expectations for pharmaceutical excipient suppliers globally.
Key Focus Areas:
- GMP principles specific to excipient manufacturing
- ExciPact guideline requirements and expectations
- Quality system elements critical for excipient suppliers: Change Control, CAPA, Risk Management
- Documentation and Data Integrity (ALCOA+ principles)
- Supplier responsibilities and customer requirements
- Deviation management and continuous improvement
- Role of quality culture in excipient manufacturing
The training balances theoretical knowledge with practical application, enabling participants to understand how GMP and ExciPact requirements translate to daily operations in excipient manufacturing facilities.