Vendor qualification is done for Raw material (Active Pharmaceutical
Ingredients/Excipients), Packaging Material (Both primary, secondary packaging
material) or any other materials.
DEFINITION:
Vendor: Who manufactures and supplies the materials (API, Excipients, and
packing material) to customers.
Supplier: Who supplies materials to customers on behalf of the vendor
API: API is defined as any substance or mixture of substances
intended to be used in the manufacture of a drug product and has
pharmacological activity.
Excipients:
An ingredient added intentionally to the drug substance which does not have
pharmacological properties in the quantity used.
Packaging Material: Any material employed in the packaging of medicinal
product, excluding any outer packaging used for transportation and shipment.
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