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АКТУАЛЬНЫЕ ВОПРОСЫ ОРГАНИЗАЦИИ ЗДРАВООХРАНЕНИЯ
N.V. Pyatigorskaya, V.V. Beregovykh, Zh.I. Aladysheva, V.V. Belyaev,
A.P. Meshkovskii, A.M. Pyatigorskii
I.M. Sechenov First Moscow State
Medical University, Moscow, Russian Federation
Automated Document Management System
of Pharmaceutical Manufacturer’s Quality Management System
in Accordance with Requirements of GMP
Drugs must be produced in compliance with good manufacturing practice rules approved by an authorized federal agency. Pharmaceutical
Quality System is a global requirement for development and production processes for pharmaceutical products. The article describes a vari-
ant of automated document management system of pharmaceutical manufacturer’s quality management system in accordance with cur-
rent requirements of GMP. The peculiarity of the proposed system is the focuses on pharmaceutical production taking into account the
characteristics and requirements for the pharmaceutical products production. All documents which are supposed to be used within the sys-
tem are grouped into the four blocks: normative legal acts, core manufacturer standards according to GMP, regulatory documents, and
register documents.
Key words
: automated document management system, pharmaceutical quality system, GMP.
(
For citation
:
Pyatigorskaya NV, Beregovykh V V, Aladysheva ZI, Belyaev V V, Meshkovskii AP, Pyatigorskii AM.
Automated Document
Management System of Pharmaceutical Manufacturer’s Quality Management System in Accordance with Requirements of GMP.
Annals
of the Russian Academy of Medical Sciences.
2017;72(2)
:126–133. doi: 10.15690/vramn808
)
DOI: 10.15690/vramn808
