At Blue Circle, quality is of paramount importance. The total commitment to quality is well explained and documented in the Quality Policy which emphasizes on meeting customer expectations and regulatory compliances.
The quality assurance (QA) department continuously upgrades the quality system by issuing the guidelines from time to time as per ICH Q7 A. These guidelines are the fundamental policies for issuing the necessary Standard Operating Procedures (SOPs). The QA is also responsible for:
The quality control department is well equipped with instruments like HPLC, GC, GC-HS, Polarimeter etc.
As per the international standards, the Microbiology section has a full developed laboratory to monitor the quality of water, API’s and testing of the facility as per cGMP requirements. The laboratory is managed by a competent and trained microbiologist.
The regulatory department compiles of high quality Technical packages and Drug Master Files (DMFs) for the APIs based on the data received from R&D and Manufacturing plants.
Regulatory department has a competent team who answer the deficiencies received from the regulatory authorities in a timely and responsible manner.
Our Regulatory team has applied CEPs and DMFs products in regulated markets.