2025-06-24-世界卫生组织-Updated_Interagency_finish_pharmaceutical_product_questionnaire_10_2024_24页_1010kb

This document is an interagency questionnaire designed for procurement purposes, based on the WHO model quality assurance system for procurement agencies. It is used to collect detailed information on finished pharmaceutical products (FPP) for shared confidential evaluation among agencies including ICRC, MSF, WHO, UNFPA, UNICEF, GDF, and TGF. The questionnaire, dated October 2024, covers administrative details, active pharmaceutical ingredients (API), FPP specifications, safety and efficacy, and commitments from suppliers or manufacturers.

Key sections include:

• Administrative section: Covers product identification, manufacturer details, regulatory status, and requirements for samples and labels.
• Active pharmaceutical ingredients: Details on API sourcing, GMP compliance, and quality documentation.
• Finished pharmaceutical product: Information on manufacturing processes, GMP inspections, stability studies, and nitrosamines risk assessment.
• Safety and efficacy: Includes bioequivalence studies, therapeutic equivalence, and periodic safety reports for innovator products.
• Commitment and authorization: Requires statements from responsible individuals and permissions for information sharing.
• Annexes and attachments: Lists required documents such as certificates, specifications, and reports that must be submitted separately in PDF format.

The questionnaire emphasizes the need for accuracy and completeness, with guidance to submit one form per product in PDF format, avoid alterations, and attach specified annexes. It is intended to ensure that all necessary documentation is provided for technical evaluations in interagency procurement processes.