Laboratory Data Integrity in FDA Warning Letters 2013

Recommendation

15/16 February 2022

Quality Control of Starting Materials (APIs and Excipients) - Live Online Training

Demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful audit or inspection for any GMP regulated quality control laboratory.

According to FDA's Pre Approval Inspection Program 7346.832, the FDA Inspector has to "audit the raw data, hardcopy or electronic, to authenticate the data submitted in the CMC section of the application. And to verify that all relevant data (e.g. stability, biobatch data) were submitted in the CMC section such that CDER product reviewers can rely on the submitted data as complete and accurate".

In the compilation of a few selected Warning Letters issued in 2013 you will find the key points regarding Laboratory Data Integrity.

The inspection focuses can be summarised and compiled in the following four themes:

1. Test Results / (Raw) Data
2. Written (Control) Procedures
3. Computerised Systems / Laboratory Instruments
4. Data Integrity Practices

Firms are responsible for the accuracy and integrity of all raw data generated in the analytical labs of the facilities. Records should demonstrate that each batch was tested and met the release specifications. These FDA Warning Letters indicate FDA's continued focus on data integrity as a central concern of its international inspection program.