Quality Control (QC)
The main aim of Quality control is to check whether the products meet the specifications and requirements of the client. We ensure that all the products that are manufactured by our company meet the standard and intended specifications of quality and purity. Our dedicated, hard working Quality Control (QC) team works round the clock to ensure that every product manufactured by us complies with all international standards of quality, purity and efficacy. Our team performs comprehensive tests according to pharmacopeias (Ph.Eur., USP, IP) for inhouse developed as well as validated analytical methods as per client requirements. The team also reviews the tests that are in compliance with ICH guidelines.
+ Our ProductsQuality assurance (QA)
Our Quality assurance team assesses client’s requirements and ensures that these requirements are met. QA systems at Maithili Life Sciences are ICH and ISO compliant. The QA systems are independent from production. The Quality assurance team ensures that API’s and advanced intermediates produced during the various stages of manufacture comply with the cGMP Requirements. Further, the QA team is responsible for site specific, maintenance, compliance, realization and advanced development of internal Quality Management Systems (QMS). They plan, direct or coordinate quality assurance programs and formulate quality control policies. Our Regulatory Affairs team works with project teams and interacts with the regulatory health agencies, such as the Food and Drug Administration (FDA) or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and anticipates what the regulatory authority will require before approving the product.
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