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 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