Continued from Part 1


  • “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.
1 1
MHRA Updates


The additional details and new topics identified in this guidance are welcome. The expanded details cover important areas for which little guidance is currently available (for example the area of IT suppliers and service providers).

The use of software as a service, platforms as a service, and infrastructure as a service continues to increase in the industry. For firms that perform gap assessments against guidance documents, particularly data integrity guidance, they would be well served by repeating that assessment with this revision of the MHRA guidance.

Many sections that were not addressed in the 2015 guidance have been added in this revision and many others have been significantly expanded in the level of detail. It does not appear that new, unexpected requirements are identified in this update, but the level of detail in explanations and examples certainly provide additional clarity and may result in a shift in firms’ interpretations.

We will continue to follow this to determine if any changes in enforcement are reported as a result.

This article originally appeared in BioProcess Online in March 2018.

About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She 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.

Unger Consulting Inc. | | 805.217.9360