Evaluation of New Risk-based Regulatory Approach to Classification of GMP Deficiencies (Review)

Introduction. This paper is devoted to analysis of a new risk-based regulatory approach to the classification of deficiencies found by inspections of medicines manufacturers, which is undoubtedly relevant.Text. The article describes the new definitions for the deficiencies found in the medicinal pro...

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Bibliographic Details
Main Authors: V. N. Shestakov, Yu. V. Podpruzhnikov
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2020-08-01
Series:Разработка и регистрация лекарственных средств
Subjects:
Online Access:https://www.pharmjournal.ru/jour/article/view/830