The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality, safety and efficacy of the drug product throughout it’s life cycle. The integrity of records and data can be breached at any time, by any employee – either intentionally or unintentionally. Data integrity failure may involve omissions, alterations, deletions, non-contemporaneous record completion or recording the completion of a task where the action has not been performed and data is not available to support. It is the responsibility of the company to ensure there are robust data management practices in place in order to provide adequate data governance.
On July 1st 2021, the new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors from PIC/S (Pharmaceutical Inspection Co-operation Scheme) came into effect. The guidance is aimed at providing guidance for Inspectorates in “planning a risk-based inspection relating to good data management practices” based on current GMP/GDP requirements and covers both on-site and remote inspections. Although the guidance is not mandatory, it provides valuable support to the inspectorate and industry alike in interpreting of data governance best practice.
Defining data governance as “the sum total of arrangements which provide assurance of data integrity”. These arrangements should ensure that data are Attributable, Legible, Contemporaneous, Original and, Accurate, as well as Complete, Consistent, Enduring and Available (ALCOA+) throughout the data lifecycle from the generation, recording, processing, retention, retrieval, use and disposal.
According to the guidance, data governance should be an integral part of a company’s Pharmaceutical Management System (QMS) and the controls in place should be commensurate with the principles of quality risk management. Data criticality (which decision does the data influence and what is the impact to product quality or safety) and data risk (vulnerability of data to alternation) should factor into a risk-based approach to data governance. The document also comments on the affect of company culture on good data governance. Cultures were employees are empowered to identify and report issues through the Pharmaceutical Quality System will best support good data governance
The new guidance will represent the baseline for inspectors to plan risk-based inspections relative to good data management practices and risk-based control strategies for data. The guidance will help the industry to interpret the existing GMP/GDP requirements relating to data integrity and will assist in meeting the requirements of a good data governance system.
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