Corporate Quality Assurance Activities
- Check of the Compliance with GMP Regulations
- Preparation and Approval of General SOPs and Validation Protocols
- GMP Training
- Check and Signature of Technical Agreements
Plant Quality Assurance Activities
- Approval of Plant Specific SOPs and Validation Reports
- CHANGE Management and Approval
- INVESTIGATION Management and Approval with Verification of Corrective Actions
- DEVIATION Management and Approval with Verification of Corrective Actions
- CLAIMS Management and Approval with Verification of Corrective Actions
- Annual Report Management with Verification of Corrective Actions
- Batch Records Control
- Supplier Audits and Supplier Validation
- Customers and Authorities Audit Management
- Check of DMF and Other Documentation for Authorities Submission
