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Quality Assurance & Validation |
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The Quality Assurance Team is
responsible for the overall cGMP (current Good Manufacturing Practices)
compliance posture of the Site, as directed by 21 CFR Parts 210 & 211, ICH
Q7A and other international quality regulations. The team is comprised of
support functions for manufacturing approval and oversight, internal and
external vendor audits, audits/inspections by regulatory bodies (e.g., the
FDA), product release and Drug Regulatory Affairs (DRA).
The Validation Department is responsible for qualifying our Manufacturing
equipment to ensure that it is installed and functioning correctly, as well
as for the validation of our Manufacturing processes. This is accomplished
by identifying critical process parameters and establishing the associated
approved operating ranges. By verifying products are made by the approved
procedure within the appropriate process conditions in properly functioning
equipment, the Validation Department helps ensure the quality of our
products. |
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