MHPRA in UK releases GxP Data Integrity guidelines20/03/2018 - Yves Dène, Lead Consultant CSV at Quality by Design
Recently, UK’s MHPRA (Medicines and Healthcare Products Regulatory Agency) released a guidance document for data integrity in the pharma industry. The publication further emphasizes the importance of regulatory practices for companies, as well as their contractors.
The guidelines can now serve as reinforcement on all good practices regulations: Good Clinical Practice, Good Distribution Practice, Good Laboratory Practice, Good Manufacturing Practice and Good Pharmacovigilance Practice.
The release encourages organisations to make data government systems a more integral part to the pharma quality systems, as described by the EU.
You can read more here.