We conduct GMP Compliance Audits of the manufacturing sites in accordance with ICH Q7, EudraLex Volume 4; Code of Federal Regulations 21 CFR Part 11, 21 CFR Parts 210-211 for medicinal products , 21CFR-110 for food products ,.21 CFR-111 for dietary supplements and PIC/s Guide and WHO Guide to Good Manufacturing Practice for Medicinal Products.
We have rich experience in conducting GLP Audits which are essential to ascertain suitability & capability of testing laboratories for its Qualify Control Infrastructure, Practices and the enforcement of Data Integrity guidelines,
We have network of associate’s offers this service exclusively under our banner. With the tough regulatory situation facing all CROs across the globe, it is crucial for all dossier developers to conduct an audit prior to initiation of a BE / Clinical Study.
A feasibility audit of a facility is conducted prior to entering into a toll manufacturing and for scaling up or tech transfer of a new product at a CMO site. This is a very important aspect often overlooked, which can adversely impact project timelines, costs and resultant revenues.
GAP Analysis Audits are conducted by us greatly to support the clients in Facility Compliance. Based on the outcome of GAP Analysis Audit and Extension of Support by deputing ours team at Site during authority inspection and Support in Post-inspection CAPA Closure for submission to the authority The guidance provided by us also includes extensive training to the staff in maintaining Compliance and going through inspections.
We also extend our support by conducting the gap audits and its compliance for EMS-14001 and OSHAS-18001