At Alembic, quality is the way of life. It is not just about SOPs and the hardware. It is an encompassing culture that is the foundation of all business decisions.
Quality steps in right from the beginning, in the form of Developmental Quality Assurance (DQA) when R&D starts development on a new product. Be it API, Analytical or Formulation R&D, DQA functions as an anchor and a partner till our best in class processes are developed. Upon completion of formula, development, the drug product is ready for bio availability studies which are conducted at our own Bioequivalence Centre, where once again Quality Assurance plays a vital role. Commercial manufacture of APIs and drug products are carried out at our manufacturing sites with quality standards second to none in the industry. We have world-class quality control laboratories at all our manufacturing locations, equipped to carry out all analysis in-house.
In fact, at Alembic, we believe that Guidelines and Pharmacopeia specifications are not the Holy Grail but the bare minimum standards to be maintained.