Sample Product Dossier for WHO Prequalification

A product dossier is a comprehensive document that contains all the information related to the quality, safety, and efficacy of a pharmaceutical product. The WHO Prequalification program requires a product dossier to be submitted by manufacturers who wish to have their products prequalified by WHO. The product dossier must meet specific requirements set by WHO, including:

1. Product Information: Include information about the product's name, dosage form, strength, method of administration, and indication for usage in the product information section. It should also include a description of the production process and specs for the completed product.
2. Quality Control: The quality control section should include thorough information regarding the quality control procedures utilized during the manufacturing process, such as testing on raw materials, intermediates, and completed products. It should also contain information from stability studies as well as any deviations from the conventional production procedure.
3. Clinical Data: Data from all clinical studies done on the product, including details about the research design, patient population, and outcomes, should be included in the clinical data section. It should also provide a synopsis of the product's safety and effectiveness.
4. Bioequivalence: If the product is generic, it must fulfill WHO bioequivalence guidelines. This section should include data from bioequivalence studies as well as any other pertinent information.
5. Packaging and labeling: The packaging and labeling section should include information regarding the product's packaging and labeling materials. A copy of the product label and packing materials should also be included.
6. Regulatory Approval: Information on the product's regulatory status in all countries where it is marketed should be included in the regulatory approval section.

Overall, the product dossier should be well-organized, properly written, and comprehensively supported by data. It should indicate that the product satisfies all of WHO's quality, safety, and effectiveness standards.

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