Perspectives in Clinical Research

QUALITY
Year
: 2010  |  Volume : 1  |  Issue : 4  |  Page : 151--155

Good clinical practice regulatory inspections: Lessons for Indian investigator sites


R Marwah, K Van de Voorde, J Parchman 
 Department of Clinical Trial and Safety, Bristol-Myers Squibb Company, Global Clinical Research and Regulatory Compliance, USA

Correspondence Address:
R Marwah
Bristol-Myers Squibb, New York
USA

Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs), protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investigational drug. In recent years, there has been a significant increase in number of inspections by different HAs, including in India. The assessors/inspectors generally do a thorough review of site data before inspections. All aspects of ICH-GCP, site infrastructure, and quality control systems are assessed during the inspection. Findings are discussed during the close out meeting and a detailed inspection report issued afterward, which has to be responded to within 15-30 days with effective Corrective and Preventive Action Plan (CAPA). Protocol noncompliance, inadequate/inaccurate records, inadequate drug accountability, informed consent issues, and adverse event reporting were some of the most common findings observed during recent Food and Drug Administration (FDA) inspections. Drug development is being increasingly globalized and an increased number of patients enrolled in studies submitted as part of applications come from all over the world including India. Because of the steep increase in research activity in the country, inexperienced sites, and more stakeholders, increased efforts will be required to ensure continuous quality and compliance. HAs have also made clear that enforcement will be increased and be swift, aggressive, and effective.


How to cite this article:
Marwah R, Van de Voorde K, Parchman J. Good clinical practice regulatory inspections: Lessons for Indian investigator sites.Perspect Clin Res 2010;1:151-155


How to cite this URL:
Marwah R, Van de Voorde K, Parchman J. Good clinical practice regulatory inspections: Lessons for Indian investigator sites. Perspect Clin Res [serial online] 2010 [cited 2019 Dec 8 ];1:151-155
Available from: http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=4;spage=151;epage=155;aulast=Marwah;type=0