Biography
Biography: Neerja S
Abstract
It is very usual and common for any pharmaceutical industry to get regulatory inspections may be in manufacturing or in a CRO. Regulatory inspections guide us to make our systems more robust The presented talk will discuss about the Inspections are of majorly two types; _ Triggered by projects submitted majorly from USFDA, EU/ UKMHRA, WHO, _ To assess the system and facility which is been applied for the facility approval to conduct the trials and analysis. Eg ANVISA, MOH Turkey, DCGI. _ Key problems extracted from various Warning letter issued in Bio-analytical investigators from where the problems can be anticipated in our labs too. Also how to have a corrective and preventive action on this so that we do not have in our scenario. For Example: o Falsified laboratory records wrt - employee time/date records inconsistent and/or falsified Analytical Procedure (AP) raw data sheets o Manipulation of Samples - FDA has determined that your firm manipulated test samples in order to meet predetermined acceptance criteria _ How we can modulate our routine practice to be prepared for the inspections without any hick ups and last minute rush. o Maintenance of all calibration and qualification records. o Maintenance access control records o Maintenance of attendance of staff o Deviations to be addressed properly. _ Focus on routine activities to bring the system and facility in line to regulatory requirements so that we can bring down the non compliances drastically. o Gap analysis o RACI/ 6 Sigma like tools . o Regular IQA and focus on the closure of the same. o System department to more focus on SOP, Protocol compliance.