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Year : 2021, Volume : 14, Issue : 2
First page : ( 1008) Last page : ( 1016)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2021.00180.3

A study of regulatory agencies inspected global drug manufacturers

Jain Sanjay Kumar1*, Jain Rajesh Kumar2**

1Ph D. Scholar, Nirma University, Ahmedabad, Gujarat, India.

2Professor-Operations Management, Nirma University, Ahmedabad, Gujarat.

*Corresponding Author E-mail: sanjaykumarjain@ymail.com


Online published on 30 April, 2021.


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. As a part of this study, 85 warning letters (www.fda.gov) issued to the drug substance and drug product manufacturers for three years (2014 to 2016) were reviewed. The qualitative and quantitative study was undertaken as a part of this study. In qualitative study, six experienced pharma professionals 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 responsdents was statistically 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. 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.



FDA, CGMP, Warning Letter, Import Alert, Data Integrity, Pharmaceutical Industry, Quality Management.


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