PROBLEMS OF CONFORMITY OF THE RECORDS INTEGRITY WITH THE REQUIREMENTS OF GOOD MANUFACTURING PRACTICE. REPORT 1. ACTUALITY OF THE RECORDS INTEGRITY CONSERVATION
Abstract
Integrity of records or data integrity is the most «hot» requirement when assessing documentation systems for compliance with Good Manufacturing Practice (GMP). It's in the center of focus of attention during inspections of pharmaceutical companies. This article is the first of a series of articles devoted to this topic. In it explains the reasons for the importance of preserving the integrity of records and provides examples of identified deviations.
About the Authors
I. A. Osmolovskaya
LLC «LexPHARMA»
Russian Federation
Russian Federation
O. V. Zarochinskaya
LLC «LexPHARMA»
Russian Federation
Russian Federation
M. O. Emelianov
LLC «LexPHARMA»
Russian Federation
Russian Federation
D. V. Somov
LLC «LexPHARMA»
Russian Federation
Russian Federation
References
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Review
For citations:
Osmolovskaya I.A., Zarochinskaya O.V., Emelianov M.O., Somov D.V. PROBLEMS OF CONFORMITY OF THE RECORDS INTEGRITY WITH THE REQUIREMENTS OF GOOD MANUFACTURING PRACTICE. REPORT 1. ACTUALITY OF THE RECORDS INTEGRITY CONSERVATION. Drug development & registration. 2017;(2):278-282. (In Russ.)
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