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Draft Guidance on Good practices for Integrity and Data Management framed by PIC/S

Updated: Dec 18, 2018

The Pharmaceutical inspection convention/Pharmaceutical inspection cooperation scheme (PIC/S) has released a draft guidance of 53 pages describing that how an inspector should examine facilities that must follow Good Manufacturing Practices (GMP) and Good distribution practice (GDP). This draft was released keeping in mind the violations of data integrity that are continuously found in FORM 483s and warning letters.

This guidance document is managed by Australian and British led PIC/S working group on data integrity and is open for discussion till 28 February 2019. It is meant to provide a balanced perspective to the inspections. The first draft of the document was published in August 2016 by PIC/S working group on data integrity which was followed by reaction from participating authorities during a six month trial execution period, after which the working group expanded and updated data.

The draft says "The quality of records and evidence is sabotaged by poor data integrity practices and susceptibility; this will ultimately weaken the quality of medicinal products"

This draft was framed as per the guidance and along with other prime concerns, it aims at providing explanatory and integrated information on strategies that are risk-based. It allows the existing needs for safety and data integrity.it also aims to provide a direction for successful execution of Good data management component into planning and GMP/GDP inspections, to serve for balancing their examinations to make sure that the quality of the inspection is meeting the data integrity expectations.

Along with inspectorate resources like aide memoire this draft will provide guidance to the inspector to make flawless use of time of inspection and examination of data integrity. The draft says" This writing should help the inspectorate in the arrangement of inspection which is risk-based related to Good data practice".