MTS Recommends... Significant Revisions and Updates to the European Pharmacopoeia

Significant Revisions and Updates to the European Pharmacopoeia
By Susanne Keitel
Pharmaceutical Technology, Volume 40, Issue 5, pg 20–21, May 02, 2016

COURSE: How to Develop Stability Indicating HPLC Methods, 2nd & 3rd June 2016, London

New Data Integrity Guidance from FDA

FDA published a new draft Guidance for Industry in April 2016 entitled, 'Data Integrity and Compliance with CGMP', the purpose of which is to clarify the role of data integrity in CGMP for drugs and the agency's current thinking on the creation and handling of data in accordance with CGMP requirements.

The document takes the form of a series of questions and answers on data integrity issues, it is assumed that these are representative of the questions commonly asked of FDA. These include several questions which were previously posted as Level 2 guidance on the FDA website (now removed) on the topics of: paper versus electronic records; shared login accounts; and use of actual samples for 'trial' injections.

I particularly like the use of the terms 'static' and 'dynamic' (previously used in the guidance: MHRA GMP Data Integrity Definitions and Guidance of Industry March 2015) to differentiate between the different types of electronic records obtained from laboratory instruments. It is a big improvement on the previous explanation of why paper printouts were not always a viable substitute for electronic records.


MTS offers a range of services related to data integrity, click here to find out more.

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