PIC/S issues final data integrity guidance (July 2021)

 

Data Integrityis defined as “the degree to which data are complete, consistent, accurate, trustworthy,andreliable and that these characteristics of the data are maintained throughout the data life cycle”.

This is a fundamental requirement for an effective Pharmaceutical Quality System which ensures that medicines are of the required quality. Poor data integrity practices and vulnerabilities undermine the quality of records and evidence,and may ultimately undermine the quality of medicinal products. 

On 1st July PIC/S issued its final data integrity guidance document for GMP inspectors. The objectives of the doucmernt are:

• Providing guidance for Inspectorates in the interpretation of GMP/GDP requirements in relation to good data management and the conduct of inspections.
• Providing consolidated, illustrative guidance on risk-based control strategies which enable the existing requirements for data to be valid, complete and reliable as described in PIC/S Guides for GMP and GDP to be implemented in the context of modern industry practices and globalised supply chains.
• Facilitating the effective implementation of good data management elements into the routine planning and conduct of GMP/GDP inspections; to provide a tool to harmonise GMP/GDP inspections and to ensure the quality of inspections with regards to data integrity expectations.
  

The doucment can be accessed here: PIC/S

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)