It is a major division at Divis and is ubiquitous being present in all facets of the organization. It is subdivided into the Quality Assurance (QA) and Quality Control (QC) units. The QA is the conceptual and policy making arm and has full supervisory and decision making authority. It is the custodian of all documentation and liaises with external agencies like ISO, FDA, EDQM etc, submits regulatory documents, supports audits, plans and executes internal audits, investigations and remedial measures, releases products for sale, schedules employee training etc. The Quality Control is the analytical wing that is extensively equipped with analytical instrumentation and trained analysts with supporting facilities. It generates the required analytical data for all quality related issues like routine analysis, investigations, validations, method development, compliance with guidelines like ICH, FDA etc, non-compliance reports, stability programs, reference and working standards qualifications, impurity profiles etc.
Quality has been the deciding factor in every activity, initiative and decision at Divis. Processes, systems, operations and decisions are aligned to ensure that the end product is of high quality. Divis realises that delivering "Excllent Quality" is the best way to market leadership in today's competitive global economy. To that end Divis has all the equipment required to monitor and ensure the production of quality products. The man-power is periodically retrained so that they are fully aware of the latest quality testing procedures and norms. Divis has invested in extensive training to incorporate the current GMP into its operating systems.
This philosophy and practice has resulted in the company being certified by various regulatory bodies in USA, UK and Europe.
The company has obtained the ISO-9001 Certification (in the year 1998) for its Quality Management Systems for its manufacturing plant and the research facilities from SGS Yarsley International Certification Services Limited, UK. Two years later in 2000 the company recieved the ISO-14001 Certification for its Environment Management Systems from the SGS International AG, Switzerland.
OHSAS-18001 Occupational Health and Safety Management Certification
The company's manufacturing facility has also been awarded the OHSAS-18001 (Occupational Health and Safety Assessment Series) Certification (in the year 2001) for the Occupational Health and Safety Management Systems for Process Design, Manufacture and services of Active Pharmaceutical Ingredients (APIs) and drug intermediates from the of Bureau Veritas Quality International (BVQI).
Good Manufacturing Practices (GMP) Certification
The company has been successfully audited by Local Drug Control Administration for WHO GMP standard and issued certificate for several APIs for both units.
European Certificate of Suitability (CoS)
The company has obtained the Certificate of Suitability for 20 APIs from the European Directorate for Quality of Medicines (EDQM), France so far for the quality of medicines, which enables the company to market its product all over Europe. The company is in the process of filing applications for the Certificate of Suitability for several other products.
The company's manufacturing facilities at Choutuppal and Chippada have been successfully inspected by the US FDA, EU, PMDA, ANVISA, KFDA and COFEPRIS.
For more information on our quality procedures you could click on the below links.
Drug Master Files
Divis currently holds 43 Drug Master Files with US FDA.