REGISTRATION DOCUMENTATION AND AMENDMENTS TO IT AS AN ELEMENT OF A QUALITY MANAGEMENT SYSTEM IN PRODUCTION OF ANTI-RABIES IMMUNOGLOBULIN (REVIEW)

REGISTRATION DOCUMENTATION AND AMENDMENTS TO IT AS AN ELEMENT OF A QUALITY MANAGEMENT SYSTEM IN PRODUCTION OF ANTI-RABIES IMMUNOGLOBULIN (REVIEW)

Introduction. Documentation is an integral part of the quality management system, a key element of production and quality control of medicines. A necessary condition for the Rules of good manufacturing practice and guaranteed production of quality products is compliance with the requirements set out...

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Bibliographic Details
Main Authors: O. A. Lobovikova, I. V. Shul'gina, E. G. Abramova, A. K. Nikiforov, A. V. Komissarov, V. A. Demchenko, A. G. Selezneva, A. S. Fes'kova, S. S. Galetova, N. P. Mironova
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-02-01
Series:Разработка и регистрация лекарственных средств
Subjects:
registration dossier
рharmacopoeia article of the enterprise
anti-rabies immunoglobulin
production biotechnology
control methods
Online Access:https://www.pharmjournal.ru/jour/article/view/653

Internet

https://www.pharmjournal.ru/jour/article/view/653

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