Quality is of paramount importance, and even more so, in the health sector where the company deals directly with precious human life. Unichem’s total commitment to quality is well-explained in the ‘Quality Policy’ laid down by the Chairman & Managing Director. The Quality Policy lays emphasis on continuous improvement, meeting customer expectations and all time regulatory compliance.
Unichem is a responsible corporate citizen and has taken several steps to integrate its quality and business objectives. The Quality System adopted by Unichem is certified by reputed international authorities like US FDA, MHRA (UK), MCC (SA), TGA (Australia), ANVISA (Brazil), WHO, EDQM (European Directorate for Quality of Medicines) and others.
The company has a full-fledged Corporate Quality and state-of-the-art Analytical Research department, which is a part of R&D centre in Mumbai. Quality system standards are continuously upgraded by the Corporate Quality centre by issuing Quality System Guidelines from time to time which become the basis for formulating standard operating procedures. The Corporate Quality centre also carries out internal audits of all manufacturing plants to check compliance with current Good Manufacturing Practices (cGMP).
All of Unichem’s manufacturing plants are certified for ISO 9001:2000 by LRQA (Lloyd’s Register Quality Assurance Limited, UK), a leading accrediting agency.
With successful registrations completed in USA, Europe, Canada, South Africa, Brazil, Japan and several other countries, Unichem’s regulatory department has matured over time to meet the challenges of the present and the future. Unichem has been able to file several ANDAs in the US apart from more than two hundred Drug Master Files in the US, Europe, Canada, Australia, Japan and several other countries.
So far, Unichem has made nine CEP (Certificate of Suitability) applications to EDQM, out of which five have been approved while some ANDAs have also been approved. The company also holds several marketing authorizations in Europe.
Unichem is amongst the first few to install, qualify and implement eCTD software for making filings as per regulatory guidelines. Dedicated teams have been put into place for handling API and Formulation-related activities.