Webinar: Validation and Maintenance of cGMP Methods

 Webinar named “Validation and Maintenance of cGMP Methods” was organized by Mettler Toledo. The webinar chaired by Dr. Christoph Jansen (Key Account Manager MT Analytical, Global technical divisional, Mettler Toledo) and guest speaker was Dr. Bob McDowall (Director, R.D.McDowall Limited). His topic named “Method Validation for cGMP and ISO/IEC 17025 tests”.

Firstly, Dr. Bob McDowall briefed some terms and abbreviations including AIQ (analytical instrument qualification), URS (user requirement specification), 4Q model for qualification (DQ, IQ, OQ and PQ), etc. Then he briefed the different between procedure and method.

And then he mentioned the purpose of QC method to assure constant quality and patient safety under cGMP, CFR, Data Integrity, etc. He also explained the different between validation and verification.

After that measurement uncertainty was introduced according to ISO/IEC 17025. 

Finally, some cases of method validation are shared such as titration methods. It included sample size, limit of quantification (LOQ), ruggedness (robustness), etc.

The different between validation and qualification were also explained that qualification is for your instrument and validation is for processes, system and methods.

Lastly, data integrity model was introduced and he briefed the draft of USP<1220> that released in May 2022, as well as, its major changes.

At the end, some literatures are shared for reference.

Reference:

Mettler Toledo: https://www.mt.com/int/en/home.html

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