Quality Assurance: Role in the Pharmaceutical Industry

DOI:

https://doi.org/10.37285/ijpsn.2023.16.5.8

Authors

  • Suruchi Agarwal Krishna Institute of Pharmacy and Sciences, Kanpur.

Abstract

Quality management system is an integral part of quality assurance. The main purpose of quality standards is to provide consumer satisfaction. Quality management of pharmaceutical products was started with production premises based on the principle of good manufacturing practices (GMP) and Food and Drug Administration (FDA) regulating bodies. Quality policy controls all critical points starting from raw material, in-process check, equipment, production, packaging material, and packing of finished goods till dispatch. The goal of quality assurance is to ensure that pharmaceutical manufacturing is done with safety, identity, quality and compliance with marketing values. It describes various documentation, records, procedures, and implementation of written procedures (SOPs) to maintain uniformity for the proper functioning of the system. The main aim of quality assurance is to prevent defects rather than detection of mistakes. According to ISO, quality management focuses on providing confidence that quality management will be improved. The process of quality assurance is to identify and analyze the information and judge the quality. The principle of quality assurance is on customer focus, leadership, process approach, continual improvement, and mutual benefit between customer and company. Quality assurance is the heart and soul of quality control. It is the sum of quality control and good manufacturing practices and another related quality system. Under the quality system products designed and controlled operations are specified in written form. There is a procedure of self-inspection for the effective evaluation of pharmaceutical quality products. There is regular evaluation and analysis of deviations and incidents, out-of-specification/trends, and change control during the manufacturing of drugs. Quality assurance staff is present everywhere to monitor each activity of the organization. So, it is considered as backbone of pharma companies without this they will be unable to manufacture products

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Keywords:

Quality assurance, Good Manufacturing Products, Quality management, quality product, Quality policy, ISO, Quality control, Quality assurance, Good Manufacturing Products, Quality management, quality product, Quality policy, ISO, Quality control

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Published

2023-09-15

How to Cite

1.
Agarwal S. Quality Assurance: Role in the Pharmaceutical Industry. Scopus Indexed [Internet]. 2023 Sep. 15 [cited 2024 Nov. 4];16(5):6999-7003. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/2826

References

Lee SH, Kim JK, Jee JP, Jang DJ, Park YJ, Kim JE. Quality by Design (QbD) application for the pharmaceutical development process. Journal of Pharmaceutical Investigation. 2022 Nov; 52(6): 649-82.

Mallikarjun PN, Kumari P, Kumar SM and Sowmya G: An overview on quality by design in pharmaceutical product development. International Journal of Pharmaceutical Sciences and Research. 2022 June 1; 13(6): 2283-93.

World Health Organization. Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Good manufacturing practices and inspection. World Health Organization; 2007.

Somareddy HK, Palamattathkuttiyil TG, Thirumaleshwar S, Gowrav MP. Impact of Automation in Pharmaceutical Industry on Roles and Responsibilities of Quality Assurance: A Review. International Journal of Pharmaceutical Quality Assurance. 2020 Mar 25; 11(01): 166-72.

Pandey P, Anju G. Quality Management System in Drug Industry-A Review. Biomedical Journal of Scientific & Technical Research. 2018 Jan 11; 2(1): 2177-9.

Ravindranath S, Mayuri D. Role of Quality Assurance Department in Pharmaceutical Industries: A. Journal of Drug Delivery & Therapeutics. 2019; 9(3): 678-83.

Leon Cruz A, Cruz LF, Singh A. Vital role of quality assurance as a backbone in pharmaceutical industry. International Journal of Advances in Pharmaceutics. 2015; 4(6):104-10.

Kushare S, Darekar A, Saudagar R. Quality Assurance and Quality Management in Pharmaceutical Science and Pharmaceutical Industry. Journal of Drug Delivery and Therapeutics. 2019 Apr 15; 9(2-s): 537-42.

Haleem RM, Salem MY, Fatahallah FA, Abdelfattah LE. Quality in the pharmaceutical industry–A literature review. Saudi pharmaceutical journal. 2015 Oct 1; 23(5): 463-9.

Yu LX. Pharmaceutical quality by design: product and process development, understanding, and control. Pharmaceutical research. 2008 Apr; 25: 781-91.

Gaurav PS, Harit K, Vandana S, Renu J, Surinder S. Quality Management System in Testing Laboratories. Research and Reviews: Journal of Pharmaceutical Quality Assurance. 2015; 1(1): 53-6.

Mazumder B, Bhattacharya S, Yadav A. Total Quality Management in Pharmaceuticals: A Review. International Journal of PharmTech Research. 2011 Mar; 3(1): 365-75.

Kothari C, Patel R. Regulatory need: harmonized PIC/S GMP, its overview and comparison with WHO GMP. Pharmaceut Reg Affairs. 2015; 4(150): 2.

Sharma S, Bodla RB, Shweta S, Pathak DP. Pharmaceutical quality management system: a review. International Journal of Drug Regulatory Affairs. 2014; 2(3): 67-8.

Simonovski N, Gjorgjeska B. Documentation as an integral part of quality assurance in the pharmaceutical industry. Knowledge–International Journal. 2022; 54(4): 807-11.

Patel KT, Chotai NP. Documentation and records: harmonized GMP requirements. Journal of young pharmacists. 2011 Apr 1; 3(2): 138-50.

Wingate G. Moving from quality control to quality assurance. Pharmaceutical Engineering. 2014 Mar; 34(2).

Patil DK, Patil DR, Pati SA. A Review on Introduction to Quality Assurance. Research journal of Pharmacology and Pharmacodynamics. 2023 Apr 1; 15(2): 73-6.

Patil AS, Pethe AM. Quality by Design (QbD): A new concept for development of quality pharmaceuticals. International journal of pharmaceutical quality assurance. 2013 Apr; 4(2): 13-9.

Krishna TV, Kumar L, Reddy MS, Muddukrishna BS, Pai KG. Market Complaints in Pharmaceuticals: A Brief Review on its Handling, Investigation and Reporting. Research Journal of Pharmacy and Technology. 2013 Nov 27;6(11):1314-16.

Shashikant GS, Chhabra G, Nayan G. Handling of market complaints and recalls, review of FDA-483 form. Asian Journal of Pharmaceutical Research and Development. 2018 Jul 10; 6(3) :55-9.

Jain AA, Mane-Kolpe PD, Parekar PB, Todkari AV, Sul KT, Shivpuje SS. Brief review on Total Quality Management in Pharmaceutical Industries. International Journal of Pharmaceutical Research and Applications. 2022; 7(05):1030-6.

Jain SK, Jain RK. Investigations and CAPA: Quality system for continual improvement in pharmaceutical industry. International Journal of Research in Pharmacy and Pharmaceutical Sciences. 2017 Nov; 2(6): 47-54.

Kumar SH, Gangadharappa HV, Gowrav MP. Handling of Pharmaceutical Deviations: A Detailed Case Study. Indian Journal of Pharmaceutical Sciences. 2020 Dec 1; 82(6) 928-44.

Dash PP, Raj R. A Methodical Review on Industrial Manufacturing and In-process Quality Control of Injectables. International Journal of Pharma Research and Health Sciences. 2020; 8(3): 3172-78.

Salunke SB, Wasmate DN, Bawage SB. Automation in pharmaceutical industry. World Journal of Pharmaceutical Research. 2022 Mar 2; 11(3): 1864-77.

Raj A. A review on corrective action and preventive action (CAPA). African Journal of Pharmacy and Pharmacology. 2016 Jan 8; 10(1): 1-6.

Ajit CP, Bhagwat AM, Chaudhari AP. CAPA: An important concept of Quality Assurance in Pharmaceutical Industry. Asian Journal of research in chemistry. 2021 Sep; 14(5): 357-62.

Thakre SS, Venkatesh MP, Gahilod RS. An Overview of Corrective Action and Preventive Action. International Journal of Pharmaceutical Investigation. 2023 Apr 1; 13(2) 224-230.

Aravindan N, Kamaraj R. Change Control in Pharmaceutical Quality Management System. Research Journal of Pharmacy and Technology. 2020; 13(4): 1987-90.

Chowdhary Y. Importance of Change control in Pharmaceutical Industry: A Review. Asian Journal of Pharmaceutical Analysis. 2023 Mar 22; 13(1): 59-60.

Ranebennur R, Thirumaleshwar S, Somareddy HK, Desai R, Sandeep DS. Development of Automated Quality Assurance Systems for Pharmaceutical Manufacturing: A Review. Journal of Coastal Life Medicine. 2023 Jan 11; 11: 1855-64.

Ahmed S, Musyuni P, Aggarwal G. A retrospective analysis on the product recall due to solvent and mineral residue issues. Journal of Generic Medicines. 2023 Mar; 19(1): 10-22.

Tiwaskar G. Identified Corrective & Preventive Action Strategies: A Regulatory Review of Pharma Industry. J. Legal Ethical & Regul. Isses. 2023; 26: 1.

Pandey K, Paliwal S, Joshi H, Bisht N, Kumar N. A review on change control: A critical process of the pharmaceutical industry. 2022 Feb 28; 11(2): 4588-92