Assessing the Correlation Between GMP Deviations and Potential Quality Defects of Medicinal Products: the Result of the Survey of Qualified Persons

Introduction. One of the key issues in the field of assessing the conformity of drug manufacturers with the requirements of good manufacturing practice (GMP) is a systematic methodology for classifying revealed deficiencies (deviations, non-conformities) by their level of criticality. Today the info...

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Bibliographic Details
Main Authors: V. A. Orlov, V. N. Shestakov
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2020-05-01
Series:Разработка и регистрация лекарственных средств
Subjects:
gmp
ema
Online Access:https://www.pharmjournal.ru/jour/article/view/768