Tuesday 29 December 2015

Review of Lab-Related Regulatory Updates in 2015

At the beginning of 2015, the MHRA in the UK published a new guidance document on data integrity: MHRA GMP Data Integrity Definitions and Guidance for Industry. Originally released in January, it was revised in March for "Added clarifications in response to stakeholder questions". This 16 page document is primarily a set of definitions, as the title suggests, together with extra information on MHRA expectations. Although it is difficult to reach agreement on exactly what is meant by some data integrity terms, I think that the guidance does a good job of providing information on how the European GMP guidance should be interpreted with respect to data integrity.

In July, the US FDA published a new Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics, July 2015. This 18 page guidance is harmonised with the ICH guidance Q2(R1), as you would expect, but provides additional detail on FDA expectations with respect to method development, content of methods, reference standards,verification of compendial methods, statistics, and method lifecycle management (including stability indicating methods, and transfer). I am a big fan of this guidance and would highly recommend a thorough read for anyone involved in managing methods. I particularly like the emphasis on method knowledge and understanding.

Also on the topic of data integrity, in September, the World Health Organization posted a new guidance on their website: Guidance on Good Data and Record Management Practices (September 2015) - Working document QAS/15.624. This 35 page document is currently a draft for comment for a restricted audience but it is readily available on the WHO website. I think that it provides a straightforward explanation of the key data integrity issues and has some good tables regarding practical implementation of ALCOA for paper and electronic records. Bearing in mind that it is a draft document I would recommend it as useful reading for anyone fairly new to the issues of data integrity to provide an understanding of the main concepts.

I haven't attempted to include pharmacopoeia updates in this blog post but there were a number of updates to both the European Pharmacopoeia and the United States Pharmacopeia. I refer you to the websites of each for more information.