Assessment of Good Manufacturing Practices (GMP) Compliance, Quality Management System, and Risk Management Capabilities
- Mock Inspections to identify risk Areas
- In-depth dssessment of manufacturing processes, quality assurance operations
- Computerized manufacturing, analytical, record-keeping systems
- Review and assessment of documentation and standard operation procedures
Assistance in Inspection Readines
- Document submission readiness
- Pre-Approval inspection readiness
- Compliance inspection Readiness
Assessment of Supply Chain Fitness and Compliance
- Inspection of Quality Management Systems
- Assessment of GMP compliance
- Assessment of supply chain suitability and risk
- Writing of SOP's, specifications & drawings, work instructions, protocols, reports.
- Equipment installation, calibration and validation.
- Suppliers audits and approval
- Master batch record
- Master Formulation Records
- Manufacturing instructions
- Packaging instructions
- Component specifications (API, excipient, container and closure System)
- Bulk & Finished Product Specifications
- Commercial stability protocol
- Manufacturing change authorization summaries
- Equipment
- Facilities
- Suppliers