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Quality Control and Assurance
Quality is an indelible trait of ours. Our corporate credo “Purity you can count on” reflects the company’s determination to ensure the offerings indeed meet the highest benchmark of standard. Our assurance of quality starts with the raw materials itself. Qualification studies are mandatory for all the equipments and all production and analytical procedures are validated. The stringency of control can be adjudged by the challenge that each analysis is effectively counter monitored at all stages. The Quality Control department exclusively uses the latest industry technologies and equipment.
We have well trained professionals in cGMP who look after the quality assurance department. A very strict monitoring of production and analytical processes ensures implementation of well-documented procedures. There is a well defined system in place for in-process quality assurance.
Regular training programs are conducted for our FDA approved chemists in production and testing department. We also invite external trainers as and when needed. Our people are motivated to attend national and international training seminars and workshops which help in developing their knowledge bank. Complementing our team of competent and experienced personnel is a wide array of sophisticated analytical instruments with which our staff has developed and adapted tests for ensuring Total Quality Management.
Documentation is said to be the key to GMP compliance and traceability of all the developments with respect to the product. At Korten, for each product the master manufacturing formula is prepared as per regulatory requirements and also to meet customer requirements. These documents are prepared by production department and are duly approved and subsequently issued by the Quality Assurance department. These documents are updated at defined intervals. The batch manufacturing and batch packing documents are prepared on the basis of these master manufacturing formulae.
There are written specifications available in Quality Control Department for testing of raw materials, packing materials, in process materials and finished dosage forms.
All operations in the manufacturing facility are covered through standard operating procedures to comply with cGMP requirements. The master copies of all documents are maintained by the Quality Assurance department.