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).
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How to cite this article?
APA Style | Patil, D. (2019). Quality Management and Quality Assurance in Pharmaceutical Development. Academic Journal of Pharmaceutical Sciences, 1(1), 16-21. |
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