QUALITY PROCESSES

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Quality is at the core of success of MAK and its range of trusted pharmaceutical formulations. Here at Mak we are fanatically committed to world class quality standards and implement CGMP processes for our products to comply with FDA, EU and JP standards. We use in-house quality control and quality assurance processes in addition to third party quality certifications to guarantee absolute reliability.

Quality Control Laboratory

  • Our unit has an independent quality control laboratory, utilizing about 26 people, spread over an area of 1800 square feet located on the first floor of the production building. The lab tests raw materials, packing materials and in process samples in addition to finished products.
  • Complete testing and analysis of raw materials is carried out in-house. If our test equipments and processes cannot test for a specific process or a specific ingredient, we get testing done by third parties.

Quality Management System

  • Quality management system controls QC equipments and processes. A well defined QMS covers quality assurance, quality control, good manufacturing practices, sanitation and hygiene. The management processes additionally incorporate complaints, validation, product recall, self-inspection, audits and processes for raw material checks, in-process checks, finished product check and checks of culture media and reagents.
  • Quality Assurance and Analytical Research & Development department under the Manager QA & QC handles all functions and reports to the General Manager and Plant Manager. It is responsible for preparing and updating quality policy, quality guidelines, issuance of raw materials, packing materials and finished products. The department is also responsible for approval of vendors and raw materials. It maintains documentation and develops analytical test methods and validation methods on an ongoing basis besides monitoring key quality indicators. The department has diverse other functions that virtually oversee all aspects of production in addition to assuring cGMP compliance and training to employees.
  • Changes or deviations are fully documented and subject to procedures.