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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.
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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.
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