A Review on Introduction to Quality Assurance

Divyashree Kantilal Patil; Divyani Rajendra Patil; Sunila A. Pati

doi:10.52711/2321-5836.2023.00015

Research Journal of Pharmacology and Pharmacodynamics

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2321-5836 (Online)
0975-4407 (Print)

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A Review on Introduction to Quality Assurance

Author(s): Divyashree Kantilal Patil, Divyani Rajendra Patil, Sunila A. Pati

Email(s): divyashree2609@gmail.com , patildivyani7779@gmail.com , sunila_patil22@rediffmail.com

DOI: 10.52711/2321-5836.2023.00015

Address: Divyashree Kantilal Patil*, Divyani Rajendra Patil, Sunila A. Pati
P.S.G.V.P Mandal’s College of Pharmacy Shahada, Maharashtra.
*Corresponding Author

Published In: Volume - 15, Issue - 2, Year - 2023

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ABSTRACT:
Quality assurance (QA) is the management technique used to provide adequate confidence that a product, service, or result will satisfy requirements for quality and be fit for use. Each monitoring program or assessment must strive to generate data that is precise, dependable, and sufficient for the specified purpose. Data quality objectives are qualitative and quantitative standards that are used to create a system that will keep the level of uncertainty within permitted boundaries and at an acceptable level. Quality assurance will boost public and funding body confidence. Unconfirmed observations should not be used until they can be verified. Robust pharmaceutical quality assurance system ensures that products are effective and safe. Following good manufacturing practices (GMP) and enacting comprehensive inspection policies help drug manufacturers produce the highest quality products and avoid reputation-damaging incidents. Product Quality Review (PQR) is a mechanism to ensure that data captured by the Pharmaceutical Quality System (PQS) is reviewed for trends. This tool can support a continuous improvement environment. PQRs are designed for the purpose of identifying and implementing recommendations for required improvements. Quality control and quality assurance jobs are all about ensuring the medication has been manufactured correctly and is safe to use, as well as having its desired effect. Without these two functions of quality management, a pharmaceutical organisation would struggle to achieve consistency in its output. Quality assurance (QA) is any systematic process of determining whether a product or service meets specified requirements. QA establishes and maintains set requirements for developing or manufacturing reliable products.

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Cite this article:
Divyashree Kantilal Patil, Divyani Rajendra Patil, Sunila A. Pati. A Review on Introduction to Quality Assurance. Research Journal of Pharmacology and Pharmacodynamics.2023;15(2):73-6. doi: 10.52711/2321-5836.2023.00015

Cite(Electronic):
Divyashree Kantilal Patil, Divyani Rajendra Patil, Sunila A. Pati. A Review on Introduction to Quality Assurance. Research Journal of Pharmacology and Pharmacodynamics.2023;15(2):73-6. doi: 10.52711/2321-5836.2023.00015 Available on: https://rjppd.org/AbstractView.aspx?PID=2023-15-2-7

REFERENCE:
1.   https://www.researchgate.net/publication/237287165
2.   https://www.researchgate.net/publication/241318869
3.   Briggs, R. 1996 Analytical Quality Assurance in Water Quality Monitoring. World Health Organization, Geneva.
4.   HMSO 1994 The Microbiology of Drinking Waters. Report 71. Her Majesty's Stationery Office, London.
5.   ISO 1984 Development and Operations of Laboratory Proficiency Testing Guide 43(E), International Organization for Standardization, Geneva.
6.   ISO 1994 Quality Management and Quality Assurance - a Vocabulary. International Organization for Standardization, Geneva.
7.   ISO 1990 General Requirements for the Competence of Calibration and Testing Laboratories. Guide 25. International Organization for Standardization, Geneva.
8.   Shewhart, W.A. 1986 Statistical Method from the Viewpoint of Quality Control. Dover Publications, New York.
9.   WHO 1992 GEMS/WATER Operational Guide. Third Edition, World Health Organization, Geneva.
10.   WHO/UNEP/VKI 1997 Analytical Quality Assurance and Control. World Health Organization, Geneva.