Quality is the prime focus at Concord. The quality management system encompasses three distinct departments namely Quality Control, Quality Assurance and Regulatory. These functions make sure that the products, processes and services meet the national and international quality standards. All manufacturing operations are carried out as per 21 CFR part 211 and ICH Q7 guidelines.
Elaborate Quality Control and Quality Assurance systems and protocols backed up by the most sophisticated analytical instruments and a well qualified team strictly follow the cGLP guidelines. Quality Control laboratory performs physical, chemical and instrument analysis of raw materials, packaging materials, in-process samples from fermentation & downstream process, finished APIs including stability programmes and analytical method development & validations. The Regulatory looks after the requirements of the national and international regulatory authorities and submits the drug master files for the drug substances.
We have been bestowed with the following accreditations:
USFDA approval
In-house R&D recognition from DSIR (Department of Science & Industrial Research, India)
cGMP compliance (State GMP certificate from local FDA)
