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Process / Packaging Manufacturing Services
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- Process Monitoring
- Streamlining and Simplification
- Process and Packaging Related Investigations
- Corrective Action and Preventive Action Plans (CAPA)
- Process Capability Assessments
- FMEA / Process Excellence
- Six Sigma
- Risk Assessment / Risk Analysis
- Quality Engineering
- Process Improvements
- Process Optimization
- Trouble Shooting
- Special Studies
- Shipping Studies
- Holding Studies
- Procedures Assessment and Upgrading
- Equipment Trials
- Statistical process Control Tools
- Six Sigma/ Process Excellence Implementation
- Raw Material Changes Qualification
- New Suppliers Qualification
- SOPs/Batch Records Review and Streamlining
- Post Approval Changes: SUPAC and Guide to Packaging Changes (Changes to NDA / ANDA's)
- Components Changes
- Labeling Changes
- Packaging Technologies
- Good Manufacturing Practices:
- 21 CFR Part 210, 211: Pharmaceutical Drugs
- 21 CFR Part 820: Medical Devices
- 21 CFR Part 809: Diagnostic Products
- 21 CFR Part 600 - 680: Biologics
- ICH Q7A : API's
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