Pharmaceutical Sciences


Quality Management and Quality Assurance in Pharmaceutical Development

Article Number: UND033088 Volume 01 | Issue 01 | January - 2019 ISSN: UA
16th Sep, 2018
15th Oct, 2018
18th Dec, 2018
23rd Jan, 2019

Authors

Deepak Patil

Abstract

Quality of medicines refers to the gathering of essential specifications. The topic of quality management is very important in pharmaceutical industries along with the importance of identity, safety, purity and ultimately appropriate quality of product, because, the products of pharmaceutical or drugs are directly supplied to the customer’s body system. The quality, safety and efficacy of pharmaceutical product are achieved by the concept of both quality assurance and quality control. The quality of the product can be maintained by taking the help of various guidelines such as GMP, GLP and many others, as it is a complex process. In every pharmaceutical industries, there is a quality assurance department who looks for the guidelines followed by the industries. In this paper, it is tried to discuss about the quality management system in the pharmaceutical industry and their elements. Along with the quality assurance, there is number of challenges, which has to be face in the pharmaceutical industries that are also discussed in this paper. Keywords: Quality Assurance, Total Quality Control, Total Quality Management (TQM), Pharmaceutical.

Introduction

The context of quality has become an important factor in the current state of the era. Nowadays people are very smart in choosing only those thing which ensures to fulfill their demands and needs. Quality can be precisely defined as the gathering or achievement of the essential specification of fast-changing world of the current scenario. Quality in reference to the pharmaceutical industry now becomes a non-ignorable issue. The topic of quality management is very important in pharmaceutical industries along with the importance of identity, safety, purity and ultimately the appropriate quality of the product, because, the products of pharmaceutical or drugs are directly supplied to the customer’s body system. There are some kinds of rules and specification has been made by several laws and guidelines which has to be strictly followed by every pharmaceutical industry. Quality Management System is a system which is followed by every pharmaceutical industry for maintaining the quality of pharmaceutical products (Pandey and Anju, 2018). Quality assurance covers all matters which influence the quality of a product individually or collectively (Potdar, 2007). Awareness for the significance of the quality of the pharmaceuticals products has been growing since the launching of cGMP-current good manufacturing practices of FDA and practices and guides which are harmonized by the world. Several definitions represents this awareness which defines the quality, as exactly as it should be. The joint statement between the federations of international pharmaceuticals (FIP), and the International Federation of Pharmaceuticals Manufacturers Associations (IFPMA) is highlighted by the role of Governments provides the pharmaceutical industry as one of the most closely structured industries for more than 50 years by certifying the safety of medicinal products to protect the patients (Haleem et al., 2013). 

References

Ahmed, Md. Mazher. “Quality Assurance & Quality Control in Laboratories: A Review.” Research and Reviews Journal of Pharmaceutical Quality Assurance, vol. 2, no. 1, Sept. 2016, pp. 26–31.

Bell, Suzanne C., and Jeff Moore. “Integration of Quality Assurance/Quality Control into Quantitative Analysis.” Journal of Chemical Education, vol. 75, no. 7, 1998, p. 874.

Fàbregas-Fernández, Anna, et al. “Quality Assurance in Research: Incorporating ISO9001:2000 into a GMP Quality Management System in a Pharmaceutical R D I Center.” Accreditation and Quality Assurance, vol. 15, no. 5, Oct. 2009, pp. 297–304.

Haleem, Reham M., et al. “Quality in the Pharmaceutical Industry – A Literature Review.” Saudi Pharmaceutical Journal, vol. 23, no. 5, 2015, pp. 463–469.

Mazumder, Bhaskar, et al. “Total Quality Management in Pharmaceuticals: A Review.” International Journal of PharmTech Research, vol. 3, no. 1, Mar. 2011, pp. 365–375.

Pandey, Priyambada, and Goyal Anju. “Quality Management System in Drug Industry: A Review.” Biomedical Journal of Scientific & Technical Research, vol. 2, no. 1, 11 Jan. 2018, doi:10.26717/bjstr.2018.02.000653.

Potdar, Manohar A. Pharmaceutical Quality Assurance. Narali Prakashan, 2007.

Rana, Tariq Mehmood, et al. “Role of Quality Management in Pharmaceutical Development: Evidence from Islamabad and Lahore.” Indus Journal of Management & Social Sciences, vol. 3, no. 2, 31 Dec. 2009, pp. 99–109.

Wangchuk, Phurpa, and Tashi ᅟ. “Quality Assurance of the University Medical Education, Hospital Services and Traditional Pharmaceutical Products of the Bhutanese So-Wa-Rig-Pa Health Care System.” BMC Complementary and Alternative Medicine, vol. 16, no. 1, Dec. 2016.

Wingate, Guy. “Moving from Quality Control to Quality Assurance.” Pharmaceutical Engineering, vol. 34, no. 2, Apr. 2014.

How to cite this article?

APA StylePatil, D. (2019). Quality Management and Quality Assurance in Pharmaceutical Development. Academic Journal of Pharmaceutical Sciences, 1(1), 16-21.
Chicago Style
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