Journal of Developing Drugs
Open Access
ISSN: 2329-6631
+44 1478 350008
ISSN: 2329-6631
+44 1478 350008
Neerja S
Piramal Clinical Research, India
Posters-Accepted Abstracts: J Develop Drugs
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 and the presented talk will discuss about: Inspections of majorly two types: (1) Triggered by projects submitted majorly from USFDA, EU/ UKMHRA, WHO, and (2) To assess the system and facility which is been applied for the facility approval to conduct the trials and analysis. For example: 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. Importance of having corrective and preventive actions so that there are no discrepancies in industrial scenario. For example, Falsified laboratory records with respect to employee time/date records that are inconsistent and/or falsified; Analytical Procedure (AP) raw data sheets; Manipulation of samples - FDA has determined that a 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 hiccups and last minute rush. Need for maintenance of all calibration and qualification records, access control records, attendance of staff. Any deviations occurred should 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. Gap analysis, and RACI/ 6 Sigma like tools, Regular IQA focus on the closure of the same. System department to more focus on SOP, Protocol compliance.