PIC/S Drafts Guidance on Good Practices for Data Management and Integrity
Posted 07 December 2018 | By
As data integrity violations continue to be found in Form 483s and warning letters, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S) released a 52-page draft guidance outlining how an inspector should inspect facilities that must adhere to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.
The guidance, which will be open for consultation until 28 February 2019, was directed by the Australian and British-led PIC/S Working Group on Data Integrity. It is meant to facilitate a harmonized approach to inspections. PIC/S published a first draft of the document in August 2016, and following feedback from participating authorities during a six-month implementation trial period, the draft was updated and expanded by the working group.
Data integrity is defined in the docfument as “the extent to which all data are complete, consistent and accurate, throughout the data lifecycle” and PIC/S says it’s fundamental in a 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,” the draft says.
This document was written, according to the guidance, with the aim of, among other priorities, providing consolidated, illustrative guidance on risk-based control strategies that enable the existing requirements for data integrity and reliability. It’s also meant to be guidance for facilitating the effective implementation of good data management elements into the routine planning and conduct of GMP/GDP inspections, and to be a tool to harmonize such inspections and to ensure the quality of inspections with regards to data integrity expectations.
“This guidance, together with inspectorate resources such as aide memoire, should enable the inspector to make an optimal use of the inspection time and an optimal evaluation of data integrity elements during an inspection. Guidance herein should assist the inspectorate in planning a risk-based inspection relating to good data management practices,” the draft says.
PI 041-1 (Draft 3) Guidance on Data Integrity.pdf
GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS