MHRA published a revision to their 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016. The MHRA Inspectorate blog says that the health authority received over 1300 comments during the consultation process.
The revision was a coordinated effort among the GCP, GDP, GLP, GMP, and GPvP inspection groups reflecting a broad source of input. MHRA specifically, however, excluded devices from the scope of this guidance. Regarding alignment with guidance from other health authorities, MHRA states:
“The GXP data integrity guidance has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education, whilst clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.”
- The MHRA guidance and WHO guidance scope includes the entirety of GXP.
- The PIC/S guidance on the same topic addresses GMP and GDP.
- The EMA and FDA guidance address GMP although the principles are relevant to GXP.
CHANGES, REVISIONS, and DELETIONS from the 2015 VERSION:
The 2018 revision of the MHRA Guidance on Data Integrity and Definitions, in general, provides more detail and granularity than the 2015 version. Several items from the 2015 version are absent from the 2018 version. Similarly, MHRA includes new topics or significantly increased detail in the 2018 version.
We address all below and identify the nature of the addition, deletion, or revision:
- Sections are addressed in the order they appear in the guidance.
- “ADDITIONS” are those sections that are new in 2018.
- “REVISIONS” generally denote expansion of sections between the 2 versions.
- “DELETED” identifies sections in the 2015 guidance that did not carry over to the 2018 version.
- We group the type of changes together within the 2 divisions in the document. Items are grouped in these 3 categories.
Click here to see the remaining (and many more) MHRA Data Integrity changes…
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About the Author
Barbara W. Unger formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.
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