Pharmacy Courses

Top Ten Data Integrity Traps

As per the FDA Warning Letters and Import alerts and even for that matter 483s issued to the Manufacturing Companies, there are multiple DI issues pertaining to different areas of QMS elements , QC areas, WH function related and Production and Engineering areas etc. and they are unlimited.

It is also significant and Evident from WHO " Notice of Concern" or EMA or other European Countries "Statement of Non-compliance" or NCs from other Regulatory agencies. But as the trend goes and DI trap areas are plenty . Here we can see top 10 list of DI Traps.

The list would be exhaustive but not not limited to::

1. Quality culture

2. Batch records

3. Manufacturing floor

4. Raw vs. recorded data

5. Lab equipment

6. Analytical documentation

7. Document control

8. Lab control procedures

9. Material management

10. Personnel

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Resource Person: Chakrapani K V C

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