Our Quality Management System is based on

- EU GMP
- 21 CFR Part 210 of FDA (cGMP)
- ICH Q7 a Good Manufacturing Practices guide for API's -   Aug, 2001.
- WHO - GMP

Harman holds GMP Certificate from Indian Drug Control Authorities (FDA), WHO - GMP Certificate and Certificate of suitability (COS) for different API's from EDQM, Strasbourg, France.

 

At Harman, Quality Control is a regulatory process, which measures actual performance, compares with standards and acts on differences, whereas Quality Assurance is an activity which provides evidence needed to all concerned, so as to establish confidence that Quality Control function is adequately performed.

In analytical services, analytical methods, equipments are validated and fully documented. The analytical service also includes stability studies and purity profiles.

cGMP-Production | Qualiy Management System | Regulatory Affairs | Research and Development