IPEC e-newsletter - Excipients Insight March 2018 - 28-03-18


Inside this issue


MHRA's GXP data integrity guide published

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published a new GXP Data Integrity Guidance and Definitions document after a consultation process that included more than 1,300 comments received from industry.

The new document – which covers Good Clinical Practice, Good Distribution Practice, Good Laboratory Practice, Good Manufacturing Practice and Good Pharmacovigilance Practice – has been drawn up to take into account changes in the way regulatory data is generated, says the agency, such as “the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working, for example, via third party service providers.”

According to an MHRA blog post authored by Tracy Moore, the MHRA’s senior GMDP inspector and GMDP operations manager, 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,” she said.




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