February 5, 2024 at 3:07 am
#5644
Hi Ashiqur!
Here is the top 10 check points for facing EU GMP audit:
1. Job Training
2. Quality Policy
3. Good Housekeeping Program
4. Equipment Qualification and Calibration Program
5. Cleaning Validation
6. Test specification and control
7. Inventory and Vendor Control Program
8. Process Validation Program
9. Reprocessing/ Reworking Procedure
10. Complaint Handling and Customer Satisfaction Program
The above list is not complete but will be important for audit preparation.