MHRA has released a new guidance document related to 'GXP' Data Integrity

[QAengineer13]

MHRA has released a new guidance document related to 'GXP' Data Integrity, this guidance comes really handy to understand the data integrity requirements.

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/687246/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf

 

[dgrainger]

This is for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA. (i.e. not medical device aspects)
Parent page is here:
Guidance on GxP data integrity - GOV.UK

 

[planB]

dgrainger,

in my experience, pharmaceutical guidelines do become relevant for medical-device manufacturers when either specific medical-device standards are missing or when medical-device standards explicitly refer to pharmaceutical guidelines. Some examples for the latter:

• endotoxin testing and other microbiological-quality tests for medical devices are typically performed per pharmacopendial methods
• biocompatibility tests for medical devices are typically performed as GLP studies
• software validation in the medical device area typically follows GxP concepts

In this way, I would regard this guidance document as being relevant for medical device manufacturers.

My 2 cents,

Gerhard

 

[dgrainger]

Gerhard,

To clarify, it has not been issued by the devices division of MHRA.

DG