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

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