Quality Assurance in Clinical Trial Patil SM, Sapkale GN, Kumbhar PB, Maske AP* ASPM's. K. T. Patil Collage of Pharmacy, Osmanabad-413 501 (MS) INDIA *Corresponding Author: A. P. Maske, ASPM's. K. T. Patil Collage of Pharmacy Osmanabad413 501(MS) INDIA. E-mail-ID: akhilxl@yahoo.com
Online published on 20 March, 2013. Abstract Clinical research is a systemic study of the drug biologic or device on human subject. Any investigation in human s meant to determine the clinical, pharmacological pharmacokinetic, pharmacodynamic, and or risk/benefits properties of a drug device or biologic. There are four phases in clinical trials. Need of quality assurance in clinical trial is for building quality in upfront assuring quality through the process. As in clinical trial we are dealing with a human life and every thing is for patient safety. When drug development reaches the stage where the drug product are produced for clinical trials in human, then compliance with the cGMP regulation is required. The drug product must be produced in a qualified facility, using laboratory and other equipments that have been validated. Operating under a State of Control produces drug products for which there is adequate level of assurance Quality, Strength, Identity and Purity The manufacturer is responsible for the quality of the Pharmaceutical product at batch release by applying GMP During manufacturing, packaging, QC testing. The product should be stable throughout the shelf-life Quality assurance for the product should be Monitoring environmental conditions under which products are manufactured/stored, air and water systems to prevent contamination, Monitoring of personnel QA at Clinical Site to Supervise, Maintain Records, Adhere to Protocol, Learn investigator procedures, Report Adverse effect, Retain Records and Train Staff. Top Keywords Clinical research, Quality assurance, pharmacodynamic, cGMP. Top |