Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review)

Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review)

Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In case of outsourcing and technical agreements there is...

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Bibliographic Details
Main Authors: A. P. Meshkovskiy, N. V. Pyatigorskaya, Z. I. Aladysheva, V. V. Beregovykh, A. M. Pyatigorskiy, N. S. Nikolenko, M. M. Marshalova, V. V. Belyaev
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2020-11-01
Series:Разработка и регистрация лекарственных средств
Subjects:
good manufacturing practice
gmp rules
medicines
drug industry
Online Access:https://www.pharmjournal.ru/jour/article/view/821

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