Please use this identifier to cite or link to this item: http://hdl.handle.net/10603/335745
Title: Best Practices in Pharmaceutical Industry A Comparative Study of Regulatory Agencies Inspected Drug Manufacturers
Researcher: Jain, Sanjay
Guide(s): Jain, Rajesh
Keywords: Economics and Business
Management
Social Sciences
University: Nirma University
Completed Date: 2020
Abstract: Pharmaceutical industry manufactures various type of pharmaceutical products like drug newlinesubstances, drug products, medical devices and bio-pharmaceuticals for the treatment of newlinediseased persons, hence product quality and patient safety is paramount vital. This is very newlinereason that this industry is highly regulated industry. In spite of stringent regulations, there is newlineincreased number of warning letters, which is a matter of concern for the manufacturers, drug newlineauthority and society. Review of the warning letters would help to identity the recurring newlineobservations and learning to other organizations to avoid similar non-compliances. newlineAs a part of this study, 85 warning letters (www.fda.gov) issued to the drug substance, drug newlineproduct manufacturers for three years (2014 to 2016) were reviewed, and causes were classified newlinein categories based on nature of observations. The qualitative and quantitative study was newlineundertaken as a part of this study. In qualitative study, six experienced pharma professional newlinewere interacted with an objective to know the reasons for issuance of warning letters. In newlinequantitative study, an instrument was developed to measures the practices regarding quality newlinesystem, data integrity management practice, laboratory control and manufacturing control newlinemanagement practices. Instrument consisting of 64 items was circulated to various pharma newlineprofessionals working in the pharmaceutical companies across the globe. newlineData collected from qualitative study were compiled and concluded that poor quality system, newlinelack of management overview, right quality culture in the organization, incorrect attitude of newlineemployees towards quality and data integrity are the major reasons for non-compliances newlineresulting into issuance of warning letter. Data collected from 317 respondents was statistical newlineanalysed and it revealed the differences in the Good Manufacturing Practices (GMP) among newlinethe pharma drug manufacturer of India and Abroad. It also revealed that GMP practices within newlineIndia are same. There is difference in GMP practices in larg
Pagination: 
URI: http://hdl.handle.net/10603/335745
Appears in Departments:Institute of Management

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01_title.pdfAttached File363.27 kBAdobe PDFView/Open
02_dedication.pdf225.68 kBAdobe PDFView/Open
03_certificate.pdf42.47 kBAdobe PDFView/Open
04_declaration.pdf44.65 kBAdobe PDFView/Open
05_abstract.pdf351.05 kBAdobe PDFView/Open
06_acknowledgement.pdf74.36 kBAdobe PDFView/Open
07_list_of_figures.pdf347.78 kBAdobe PDFView/Open
08_list_of_tables.pdf353.4 kBAdobe PDFView/Open
09_abbreviations.pdf234.32 kBAdobe PDFView/Open
10_contents.pdf535.25 kBAdobe PDFView/Open
11_chapter_1.pdf1.51 MBAdobe PDFView/Open
12_chapter_2.pdf886.86 kBAdobe PDFView/Open
13_chapter_3.pdf715.83 kBAdobe PDFView/Open
14_chapter_4.pdf959.28 kBAdobe PDFView/Open
15_chapter_5.pdf688.08 kBAdobe PDFView/Open
16_chapter_6.pdf558.99 kBAdobe PDFView/Open
17_appendix.pdf791.57 kBAdobe PDFView/Open
18_references.pdf583.17 kBAdobe PDFView/Open
80_recommendation.pdf533.89 kBAdobe PDFView/Open
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