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Basic technical specifications for evaluating the acceptability of the biological-biotechnological products to be procured through the Revolving Fund or Strategic Fund
- General description of the product, including the brand name, formulation, available presentations, expiration date, and form of administration.
- Description of the manufacturing process.
- Quality control and product specifications (Pharmacopoeias, CFR, etc.)
- Release certificates for finished products issued by the NRA of the country of manufacture. In addition, release certificates for plasma in the case of blood products.
- Natural and accelerated stability studies at temperatures of 25ºC, 37ºC, 45ºC)
- Specimens from the primary and secondary vacuum container system, labeled as finished product
- Labeling and packaging material in English and Spanish (sample labels, inserts, and packaging for prefilled vials, ampoules, syringes, etc.)
- Good Manufacturing Practices Certificate, issued by the NRA that releases the product, for all entities involved in the manufacturing process.
- Clinical trials that reveal the safety and efficacy profile of the product, approved by the National Regulatory Authority that granted the product license.
- Summary production and control protocol for the product that describes every step in the manufacturing process and the controls performed at each stage. This protocol should be based on the WHO standards for the manufacture and control of each product.
- Information on the electronic devices used in the course of product storage and transport, based on the storage temperature recommended by the manufacturer, the stability of the product, and the WHO recommendations for each case.
Last Updated on Thursday, 04 March 2010 11:10