Wednesday, 29 May 2019

MHRA GXP Data Integrity Guidance

An interesting MHRA blog post has been posted, looking at data integrity from the GCP perspective. The blog is from Paula Walker.

Here is an excerpt:

“The guidance describes the need for a documented audit trail review, where the need for and extent of such evaluation is identified in the trial risk assessment, performed prior to the trial commencing.  This could include evaluation of data points associated with critical/complex trial processes, in other words, where the trial risks are.  This has led many to question whether this means that sponsors, or indeed Clinical Research Organisations (CROs) working on behalf of sponsors, need to develop a generic audit trail review Standard Operating Procedure (SOP) that covers this process, that is, an SOP not specific to a particular clinical trial as part of their quality system. 

To answer this question, we would refer organisations back to the statement that the need for a review of an audit trail should be determined by a risk assessment based on the requirements of the trial, taking into account the systems, procedures and controls in place to be used in the trial.  Therefore, to have a generic SOP would probably not add any benefit to this process and is not mandated by the guidance or expected by GCP inspectors.”

To read the whole blog, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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