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At Anwita we give very importance to the quality and all of our formulations were with high quality standard.
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Our Quality assurance team assesses client’s requirements and ensures that these requirements are met. QA systems at Anwita Drugs & Chemicals are ICH and ISO compliant. The QA systems are independent from production.
The Quality assurance team ensures that Finished Dosage forms and Semi-finished products 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.
The Company is committed to achieving customer satisfaction by the use of quality procedures which will be operated to meet or exceed the requirements of ISO 9001-2015.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. Our Regulatory Affairs personnel are responsible for tasks involving evaluating dossiers/queries and compilation of critical dossiers and queries, as and when required. They are also responsible for registration of products in various countries abroad as per the registration guidelines as well as filing of DMF’s in regulated markets.
The many responsibilities of the QA team include, but are not limited to:
At Anwita we give very importance to the quality and all of our formulations were with high quality standard.