Article

Elements of Pharmaceutical Quality System
Deepthi Suri* , Kumar Raja Mulakala

Details

Author

Deepthi Suri*

ISSN

2319-5622

DOI

doi.org/10.5281/zenodo.3933359

Published on

Jul 07, 2020

Abstract

A harmonized pharmaceutical quality system is applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science. The main objective behind the establishment of a Pharmaceutical Quality System is to establish, implement and maintain a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approved regulatory filings) and other internal and external customers. Identification and implementation of the appropriate product quality improvements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancements, thereby increases the ability to fulfil quality needs consistently. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International standards Organization (ISO) quality concepts. The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the differences among, and the different goals of each stage.

Keywords

ICH Q10, Quality, Quality Risk Management, Process Improvement, ISO

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