In Moscow, a two-day workshop dedicated to the basic principles of data integrity assurance in drug manufacture and quality control was launched. The Head of Good Engineering Practice Department of FSI «SID & GP» Mr. Igor Falkovskiy explained the regulator’s position towards data integrity to workshop attendees.
At the topical workshop organized by FAVEA Group, the Head of Good Engineering Practice Department of FSI «SID & GP» Mr. Igor Falkovskiy presented the industry guideline «Data integrity and computerized systems validation».
Data integrity is defined as «the degree of completeness, accuracy and consistency of data throughout the entire data life cycle» and has a fundamental meaning in the pharmaceutical quality system. Data integrity is applied to all elements of the quality management system. The principles set forth in the guideline are equally applicable to both electronic and paper-based data. Assurance of data integrity embedded into the pharmaceutical quality system is meant to guarantee the quality of drugs manufactured and the quality of decisions made, and it explains the high interest expressed by pharmaceutical facilities to this topic.
The guideline is aimed at utilizing the risk-based approach in data management, which includes risk, criticality and data life cycle, and serves to help pharmaceutical manufacturers to identify the data having the maximum impact on GMP-processes, to define and implement the most effective and robust control based on risk assessment.
As a reminder, last year, FSI «SID & GP» with the support by PQE, presented the data integrity guideline. The requirements and methods expressed in the guideline are aligned with the expectations defined in the guidances of competent associations, such as WHO, PIC/s, ICH and ISPE.
At the workshop, Mr. Igor Falkovskiy said that the guideline presented should be considered as a tool for understanding the position of the Department of Pharmaceutical and Medical Industry Development of Minpromtorg of Russia and of FSI «SID & GP» towards data integrity.