Not least because of the warning letters made public by the US FDA it has been shown that DI has become a serious issue over the past few years. In today’s data-driven world the quality and integrity of data is imperative and the regulatory authorities worldwide published guidance documents to underpin their expectations on data management and data safety. The WHO and the EMA (Q&A) have already released final documents. Now the MHRA has followed. There has been significant stakeholder interest in the development of the guide, as illustrated by the receipt of over 1300 comments from industry, and trade and professional groups across all GXPs during the consultation process. According to the MHRA data integrity team, the comments received have all been taken into consideration. It comes as no surprise that the final version has grown considerably in size, which is now 21 pages compared to 14 pages of the draft.
Some content amendments:
All in all, it can be said that 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. Those documents are also listed as references.
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