A division of Zaneka Pharmaceuticals Pvt. Ltd.

Quality Control

Our Company follows all the strict norms and regulations laid under Food and Drugs Act, 1940 and 1945. Our manufacturing units are certified by ISO 9001-2008 and GMP. Strict facilities and restrictions have been made on following the guidelines as per Schedule M. The whole drug development and pharma manufacturing is done under hygienic & systematic conditions. Our company has the best capacity and capability to amalgamate into the supply chain for solid and liquid drugs dosage forms.

Total Quality Management is achieved by-Confirming to GMP Standards. All the job functions of the company are in time with its Quality policy. Total Quality Management of the firm is located after by a Quality Assurance Executive. All department heads up to the Managers, maintain and follow Quality Management System are guided and coordinated by the Quality Assurance Executive.

The Quality Management Assurance with the help of any other personnel has the responsibility to see that all procedures are as per the standard operating procedures. Personnel competence is also assessed by the Quality Assurance Executive. The total Quality Management System is designed for ‘Zero Defect Product’ for which the Quality Assurance Executive is responsible.

All evaluation of procedures and validations are done by the Quality Assurance Department.

The factory is having its own fully equipped laboratory with almost all the In-House testing facilities of the products being manufactured.

It is also having adequate, competent Technical Staff to carry out the Manufacturing Operations Analysis.

The Quality Assurance Department is responsible for: Preparing, issuing and updating Quality Assurance Policy. Maintaining and controlling all documentation related to technology transfer.

The Quality Control Department is part of the Quality Assurance Department. It is headed by a Quality Control Manager. The major activities of the Quality Control Department are: Approve / Rejection of raw and packaging materials as per respective SOP.

  • Testing of in-process samples as per respective SOP.
  • Testing of finished goods as per respective SOP.
  • Carrying out stability studies as per respective SOP.
  • Testing of water as per respective SOP.
The Company has a defined Self Inspection System through which all manufacturing functions, Engineering Department, Quality Control Department and warehouse are audited by a team of Managers consisting of Works Manager, Q.A. Manager and Production Manager and the Department Head of Department being audited. The audit is carried out as per the SOP.

Quality Policy

To manufacture and market pharmaceutical formulations of requisite standards to comply with customer needs, enhance customer satisfaction and continuously improve the effectiveness of the quality management system This shall be achieved by implementing the practices in processes and systems, updating and conforming to applicable regulatory requirements, continuous and dynamic improvements in quality of products and services.