Laboratory Data Integrity in FDA Warning Letters 2012

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 attached compilation of a few selected Warning Letters issued in 2012 we have summarised for you the key points regarding Laboratory Data Integrity.

The inspection focuses can be summarised and compiled in the 3 following themes:

1. Test Results / (Raw) Data
2. Written (Control) Procedures
3. Computerised Systems

All these topics and further important aspects about the present regulatory requirements and relevant critical regulatory observations concerning laboratory data integrity and security will be covered in detail and discussed in ECA's Education Course "Raw Data, Results and Reportable Values" from 14 - 15 May 2013 in Prague.