Auditing in clinical research has evolved over the years to be far more value-added to an organisation than only assessing compliance with regulations. The clinical auditor, whilst conducting a vast array of different audits, also acts as a consultant and quality adviser to the functions involved in the drug development process, providing 'trouble-shooting' advice and interpretation of regulations and guidelines. There were times when auditors were considered as people doing nit picking, fault findings, policing etc but now the mind set of people has changed. Today QA is taken as one of the integral functions in Clinical Research and walks hand in hand with the mainstream to carry out the gap analysis and systems improvement.
Foreign And Indian Regulatory Authorities Getting More Stringent Now
As per recent report1, The US Food and Drug Administration has been criticized for reviewing only a fraction of foreign drug trials, despite an increase in the number of pharmaceutical companies moving drug testing overseas. “As sponsors increase the number of foreign clinical trials in support of FDA marketing applications, the agency’s current method of using inspections to ensure human subject protections and data validity is becoming increasingly strained,” warned Inspector. Findings show 80% of marketing applications contain foreign trial data and FDA inspected clinical investigators at less than 1% of foreign sites and only 1.2% of clinical trial sites for applications approved in FY 2008. The agency inspected 1.9% of domestic clinical trial sites and 0.7% of foreign clinical trial sites. Thus, bottom Line is that USFDA may start on site inspections of drug testing centres on humans in India soon.
As per the recent published news2, Indian regulatory officers will carry out random on-the-spot inspections on clinical trial sites to check deviations from July 2010. Random on-the-spot inspections on clinical trial sites to ensure their compliance with the current Good Clinical Practice (GCP) norms is among a series of new reforms to have an extensive regulatory system for clinical trials the regulatory agency is planning to bring in the next eighteen months, according to Drug Controller General of India (DCGI). Regulatory inspectors will visit trial sites with updated checklist in random to verify the compliance of standard practice norms from July. Also, The Drug Controller General of India (DCGI) brought out a notification to this effect informing the applicants to register the clinical trial in ICMR Clinical Trial Registry before initiating the trial process.. Registration of clinical research organizations which conduct human studies on drugs, cosmetics and medical devices would also be made mandatory in India. With these new developments, it is therefore mandatory to keep a tight control on the quality brick by brick for all the key stakeholders. Thus, external agencies are helpful to doing this for sponsors due to several compelling reasons.
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