AUTOMATED DOCUMENT MANAGEMENT SYSTEM OF PHARMACEUTICAL MANUFACTURER’S QUALITY MANAGEMENT SYSTEM IN ACCORDANCE WITH REQUIREMENTS OF GMP | Zendy

N.V. Pyatigorskaya | Zendy; В. В. Береговых | Zendy; Zh. I. Aladysheva | Zendy; V. V. Belyaev | Zendy; A. P. Meshkovskii | Zendy; A. M. Pyatigorskii | Zendy

Open Access

AUTOMATED DOCUMENT MANAGEMENT SYSTEM OF PHARMACEUTICAL MANUFACTURER’S QUALITY MANAGEMENT SYSTEM IN ACCORDANCE WITH REQUIREMENTS OF GMP

Author(s) -

N.V. Pyatigorskaya,

В. В. Береговых,

Zh. I. Aladysheva,

V. V. Belyaev,

A. P. Meshkovskii,

A. M. Pyatigorskii

Publication year - 2017

Publication title -

annals of the russian academy of medical sciences

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.122

H-Index - 15

eISSN - 2414-3545

pISSN - 0869-6047

DOI - 10.15690/vramn808

Subject(s) - quality (philosophy) , quality management system , good manufacturing practice , business , production (economics) , agency (philosophy) , management system , process management , risk analysis (engineering) , computer science , quality management , operations management , engineering , supply chain , marketing , epistemology , economics , macroeconomics , philosophy

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 variant of automated document management system of pharmaceutical manufacturer’s quality management system in accordance with current 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 system are grouped into the four blocks: normative legal acts, core manufacturer standards according to GMP, regulatory documents, and register documents.

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