Best Practices in Pharmaceutical Industry: A Comparative Study of Regulatory Agencies Inspected Drug Manufacturers

Abstract

Pharmaceutical industry manufactures various type of pharmaceutical products like drug substances, drug products, medical devices and bio-pharmaceuticals for the treatment of diseased persons, hence product quality and patient safety is paramount vital. This is very reason that this industry is highly regulated industry. In spite of stringent regulations, there is increased number of warning letters, which is a matter of concern for the manufacturers, drug authority and society. Review of the warning letters would help to identity the recurring observations and learning to other organizations to avoid similar non-compliances. As a part of this study, 85 warning letters (www.fda.gov) issued to the drug substance, drug product manufacturers for three years (2014 to 2016) were reviewed, and causes were classified in categories based on nature of observations. The qualitative and quantitative study was undertaken as a part of this study. In qualitative study, six experienced pharma professional were interacted with an objective to know the reasons for issuance of warning letters. In quantitative study, an instrument was developed to measures the practices regarding quality system, data integrity management practice, laboratory control and manufacturing control management practices. Instrument consisting of 64 items was circulated to various pharma professionals working in the pharmaceutical companies across the globe. Data collected from qualitative study were compiled and concluded that poor quality system, lack of management overview, right quality culture in the organization, incorrect attitude of employees towards quality and data integrity are the major reasons for non-compliances resulting into issuance of warning letter. Data collected from 317 respondents was statistical analysed and it revealed the differences in the Good Manufacturing Practices (GMP) among the pharma drug manufacturer of India and Abroad. It also revealed that GMP practices within India are same. There is difference in GMP practices in large and small organizations with respect to based on annual turnover and employee strength in India, while there is no difference in GMP practices in large and small organizations with respect to based on annual turnover and employee strength. Issuance of warning letter and import alert has significant impact on continuity of the business, as there is loss of trust among partners, regulators and customers. There is loss of business opportunity and manufacturer has to spend time and money to revive the quality system meeting Agency’s expectations. There is need for Paradigm shift in quality culture and transparency. Quality, compliance and integrity are the pillars for any pharmaceutical organization to be successful. The thesis is structured as follows. Chapter 1 gives introduction to pharmaceutical industry, Evolution of GMP, regulatory requirement, USFDA inspection system and warning letter. Chapter 2 is about review of literature, USFDA communique, and current challenges in pharmaceutical industry. This chapter further provides the research gap, research questions and objective of research. Chapter 3 is about data collection tool, sample size and sampling frame, sampling technique used in the study, analysis tool and development of hypotheses. Chapter 4 gives overview of data analysis, out of qualitative study and testing of hypotheses. Chapter 5 is about results and discussion and contribution of the study. Final Chapter 6 gives overall summary and conclusion, limitation of the study and scope of future study for research.