Mandatory Activities for GMP Authorization of a New Pharmaceutical Facility

Obtaining GMP authorization for a new pharmaceutical facility entails a detailed process to ensure regulatory compliance and safe product production. Here's a comprehensive overview of necessary activities:

1. Facility Design and Construction:

- Develop layout adhering to GMP, zoning different areas.

- Construct with materials preventing contamination.

2. Cleanroom Design and Qualification:

- Design cleanrooms meeting GMP air quality, temperature standards.

- Qualify cleanrooms through IQ and OQ.

3. QMS Implementation:

- Establish robust QMS covering documentation control, change management, deviations, CAPA, and risk.

4. Equipment and Utility Qualification:

- Qualify equipment via IQ, OQ, and PQ for proper installation.

- Validate utilities like HVAC, water, and compressed air.

5. Validation of Critical Processes:

- Validate manufacturing processes (formulation, blending, etc.).

- Perform PPQ to demonstrate consistent results.

6. SOPs:

- Develop SOPs for operations, training, adherence.

7. Batch Records and Documentation:

- Create detailed batch records with step-by-step instructions.

- Implement documentation system for activities, deviations, changes.

8. Quality Control and Testing:

- Establish well-equipped QC lab for raw materials, finished products.

- Validate analytical methods for accuracy.

9. Stability Studies:

- Conduct stability studies for shelf life, storage conditions.

- Analyze data for performance assessment.

10. Supplier Qualification:

- Qualify suppliers for quality, GMP compliance.

11. Environmental Monitoring:

- Set up comprehensive environmental monitoring to control contamination.

12. Employee Training and GMP Awareness:

- Train on GMP, hygiene, facility-specific procedures.

- Ensure personnel know compliance responsibilities.

13. Regulatory Submission Preparation:

- Compile required documentation for regulatory submissions.

14. Regulatory Inspection Readiness:

- Prepare for regulatory inspections, ensuring processes and documentation are in order.

15. Continuous Improvement and Risk Management:

- Encourage continuous improvement, risk mitigation.

16. Qualification of Qualified Person (QP):

- Appoint QP for product release compliance.

17. Cross-Functional Collaboration:

- Foster collaboration between departments for GMP alignment.

18. Technology Transfer and Process Validation:

- Transfer technology from development to manufacturing.

- Validate processes for consistency.

19. Record Keeping and Archiving:

- Establish record-keeping and archiving procedures.

20. Management Review and Oversight:

- Conduct management reviews for GMP effectiveness.

Note: GMP requirements may vary based on regulatory authorities (e.g., FDA, EMA).

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