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GMP Supplier Assessment Questionnaire for Active Pharmaceutical Ingredients (API) and ExcipientsStandard draft to adapt and expand
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The extent of supplier assessment depends on the significance of the supply. The more important the supply, the more information should be asked of the supplier to include it in the risk assessment. The GMP-Supplier Questionnaire for APIs and Excipients consists of: - Part 1: Preliminary information on the supplier and the manufacturer - Parts 2 to 8: Detailed information on the manufacturer: 2 Quality management system of the manufacturer 3 Personnel 4 Premises and Equipment 5 Documentation 6 Production 7 Quality Control System 8 Distribution, Complaints, Product Defects and Recalls
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For auditors and manufacturers of drugs and APIs.
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