International – WHO Drafts Guideline on Data Integrity for Pharmaceuticals

The World Health Organization (WHO) recently drafted a new guideline on data integrity that explains the important elements to ensure the reliability of data and information in the production and control of pharmaceuticals.

WHO echoed similar concerns expressed by the US Food and Drug Administration (FDA) (even among some larger biopharma companies) in noting an uptick in recent years of the number of observations regarding the integrity of data, documentation and record management practices during inspections of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP).

“Possible causes for this may include (i) too much reliance on human practices; (ii) the use of computerized systems that are not appropriately managed and validated; and (iii) failure to adequately review and manage original data and records,” the 28-page guideline says.

While recommending companies use a written data integrity policy, the guideline outlines the principles of data integrity and good documentation practices before delving into quality risk management…