In general, FDA inspectors assess current cGMP compliance of the pharmaceutical manufacturing site and issue a detail report.
That's why a pharmaceutical company should always be inspection ready and in order to facilitate the preparation activities here are a checklist to consider on an ongoing basis:
1. Maintain a list of the key and trained SMEs both internally and externally
2. Maintain up to date processes and associated procedural documents
3. Create and maintain documentation that is concise, factual and complete. Documents should be clear and self explanatory.
4. Proactively review systems using KPI, metrics and other tools available to identify areas for process improvements and compliance. Review and assess data output that will give a clear vision of the state of compliance.
5. Ensure deviations and CAPAs are clearly documented and address the issues identified - see also previous point about documentation.
Inspection readiness starts within a company with the establishment of processes and systems that proactively support compliance and a company that embraces a culture of quality.
Following documents or procedure should also be up to date as a FDA inspection readiness -
- Site Master File
- Manufacturing licence
- Registration Dossier
- Previous Inspection Records
- Quality Manuals
- SOPs
No process or system is completely perfect but the approach taken to manage your processes and systems and how gaps are managed is what makes the difference and a company successful.
Read also: Regulatory Inspection Management in Pharmaceutical Industry
Required Documents Relevant to FDA Filing
- Batch Records (Stability, Exhibit, PO etc.)
- Stability Report
- PDR
- Testing Data
- Cleaning Validation Assessment
- Hold Time Study Report
- Raw materials recipient
- Nitrisamine & Elemental Impurities Risk Assessment
- HVAC & Water System
- Change Records
Related:
- What to do Before, During and After FDA inspection?
- FDA Drug Compliance Programs
- Trend of FDA Warning Letters
- Discussion Topics of the FDA 21 CFR Part 211
Resource Person: Stephanie Martin MRQA
