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UK MHRA Aims To Address "Fundamental Failures" In Data Integrity

 
• By Vibha Sharma

The UK MHRA's revised guidance on maintaining the integrity of data throughout the chemical and pharmaceutical development lifecycle is intended to address various shortcomings identified by regulators during inspections.

Data Integrity

The UK Medicines and Healthcare products Regulatory Agency is inviting feedback on an updated guideline on data integrity issues, which has been substantially revised in scope to cover all aspects of pharmaceutical development and good laboratory practice studies regulated by the agency.

Also, the updated document addresses some gaps in the previous version of the guideline and clarifies expectations where inspections showed "an unexpected interpretation of the [MHRA's] requirements," the agency said...

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