The document offers a detailed framework for the procurement of pharmaceutical products. The primary objective is to align WHO pharmaceutical acquisitions with established normative standards and guidelines, ensuring their rational use across various healthcare settings.
The guide's General Information section underscores WHO's commitment to facilitating timely access to high-quality pharmaceutical products. The selection of these products is heavily influenced by the WHO Model of Essential Medicines List and specific disease treatment guidelines. In the Product Information section, the emphasis is placed on the accurate identification of products in compliance with WHO technical specifications. It highlights the significance of identifying products by their International Non-proprietary Names (INN) and the imperative for clear active ingredient labeling.
Addressing Manufacturing Sites, the guide mandates suppliers to specify the name and address of the manufacturing location and present a valid GMP certificate. Suppliers are also obligated to inform WHO of any changes in the GMP certificate status or manufacturing facilities. The Shelf Life and Storage section dictates that products should have a clearly defined shelf life and storage conditions. For cold storage products, adherence to WHO's storage and transport guidelines is crucial.
The responsibility of ensuring the Quality of Goods rests with the supplier. Any product that doesn't meet the standards must be replaced at the supplier's expense. WHO also retains the right to conduct technical visits and audits to verify product quality. Lastly, the Packaging and Palletization section emphasizes that packaging should be appropriate for the transport mode, compliant with international and national regulations, and capable of safeguarding the goods during transport and storage in diverse climatic conditions.
The guide serves as an invaluable resource for suppliers, setting the benchmark for the quality and safety of pharmaceutical products procured by WHO.
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