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The quality system requirements to identify, select, approve and qualify suppliers/Vendors of all materials used in the manufacture of APIs and medicinal products. sentation of a new supplier (manufacturer and supplier), preliminary assessment using a questionnaire, evaluation of samples before shipment, formal meeting of the buyer for technical coordination (optional), annual calendar of the vendor audit program, audit vendor quality system, production performance system, reports and monitoring and final approval/rejection. The procedure will be applicable to the starting material required for bulk pharmaceuticals, pharmaceuticals, and packaging materials.

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