Wednesday 18 March 2015

New 'Data Integrity Definitions' Guidance from MHRA

The MHRA has published a new set of guidance relating to data integrity: Good manufacturing practice: data integrity definitions. First published on 23rd January 2015, the guidance was revised on 13 March 2015 following stakeholder feedback.

The description provided on the MHRA website reads as follows:

"This guidance sets out our expectations for data integrity in good manufacturing practice (GMP).

It complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4."

MTS offers a range of services related to laboratory data integrity including auditing, training courses, and consultancy. Our new training course, 'Laboratory Data Integrity', is comprised of three days, you can attend any preferred combination of days: 

1: Introduction to Laboratory Data Integrity; cGMP in the Pharma Lab
Day 1 introduces the fundamental concepts of laboratory data integrity in the context of working within a quality management system and as such this course also acts as an introduction/refresher to laboratory cGMP.

2: Applying Data Integrity in the Laboratory; Minimising Analytical Error
Day 2 deals with the effects of analytical errors on laboratory data integrity. This involves building an understanding of the nature and sources of analytical errors so that their effects can be minimised during testing, leading to high standards of data integrity and reduced numbers of OOS/OOE results due to laboratory errors.

3: How to Improve Data Integrity in the Pharma Lab
Day 3 focusses on improving laboratory data integrity and associated quality management systems by review of laboratory processes to identify data integrity risk, and implementation of appropriate solutions, paying particular attention to deficiencies that are commonly cited by regulatory authorities.

Visit the MTS website for more information and details of the open enrolment dates and locations, or Contact us to find out more.


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