GCP Inspections

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GCP Inspections By

PWAC Business Solutions Pte. Ltd.

Good Clinical Practice (GCP) is a set of international quality guidelines about the protection of human rights and the safety of human test subjects involved in clinical trials and research. These guidelines ensure that the research or the trial of a new drug on human test subjects is carried out under due care so as to protect these human subjects.

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Types of GCP Inspections ďƒ˜ Risk-based Inspections These inspections are categorized on the basis of assessments into low, medium and high risk. Inspections of high risk category companies are always prioritized! For other low and medium risk companies, inspections are conducted at random.

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ďƒ˜ Triggered Inspections These are ad-hoc inspections which are triggered due to complaints or suspected violations of GCP guidelines! And in most triggered inspections, organizations are not informed about the inspection beforehand.

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ďƒ˜ Routine Inspections These inspections are conducted from time to time and are announced before being conducted. These inspections are usually conducted only on those trials which are still ongoing or are close to being complete.

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CONTACT US for More Information

Address: 14 Robinson Road #13-00 Far East Finance Building Singapore - 048545

Phone No.: (65) 6638 1232, (65) 97488054 Email ID: enquiry@pwac.com.sg

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