Quality Assurance

Home. Quality Assurance

MAKCUR Laboratories Ltd.


At MAKCUR, we believe that Quality Assurance is all about protecting the final users of the drugs. It is an assurance to the patients that the production processes held to manufacture the final drugs are all planned in accordance with safety guidelines laid down by various quality assurance agencies across the globe. For us quality assurance is to understand the quality guidelines and regulations in order to meet the safety and efficiency expectations of the end user.

At MAKCUR, quality assurance is detailing of the processes held, whether the processes held gave desired results and detailed results that were observed. We believe in execution of flawless processes in order to maintain high quality standards. We have a team of Quality Assurance Manager and executives to study the test results and analyse them. The basic functions involved in our quality assurance department include:

  • To generate, revise and implement specification
  • To prepare, revise and implement SOPs
  • To validate the vendors
  • To conduct internal audit and investigation
  • To develop, propose and implement in house specification
  • To handle market complaints
  • To propose, develop and formulate new dosage forms
  • To conduct stability studies
  • To maintain storage of quality records and control samples

The various duties of our quality assurance team at different levels of production includes

Manufacturing: Checking and approving documents based on WHO/TRS through the production processes like batch manufacturing record, standard operating process and approving documents related to production and quality control departments

In order to assure quality at every level of production, we ensure that we guide our team by
  • Train team as per GMP and WHO guidelines
  • Preparing and handling SOP
  • Ensure line clearance for all departments
  • In process quality control checking
  • Record verification
  • Release the batch of product for marketing
  • Handling market complaints
  • Checking the stability of the product
  • Timely validation and calibration of equipments

At MAKCUR, we are continuously in a process of bringing transformation in our working and in our systems for better quality. We are always in touch with our compliance teams in house and in the market to get feedback that can be used to work for betterment. We encourage proposals for corrective and preventive actions and we undertake annual product review. Our team also undertakes an annual trend analysis of various quality parameters for products, environment and water to derive to problems faced and steps that can be taken to resolve them.