Quality Control
Pharmaceutical products and insecticides supplied through the Strategic Fund are subject to certain requirements in quality control. Manufacturers and suppliers of multisource pharmaceutical products are required to provide a Certificate of Analysis per batch of product supplied to a country. In addition, the Certificate of Analysis must comply with international norms as specified in the International Pharmacopoeia (IP), The United States Pharmacopoeia, The European Pharmacopoeia (EP), The British Pharmacopoeia (BP), or with other specifications as required by PAHO.
Member States participating in the Strategic Fund are expected to implement quality control tests according to specifications and national requirements. Tests should be completed within a reasonable period, and not later than 60 days after the date of receipt at the principal storage location within the country.
PAHO reserves the right to use a laboratory of its choice to execute quality control testing of Strategic Fund products, prior to or following shipment, or to obtain and retain samples of a batch of product and/or the active pharmaceutical ingredient. In such cases, the cost of quality control testing is to be borne by the supplier. Quality control testing of insecticides is executed independently by a PAHO/WHO Collaborating Center selected by the Organization, after receipt of the product at the principal storage site. The Quality Control evaluation of pesticides must comply with the Pesticide Evaluation Scheme 'WHO Specifications for Pesticides Used in Public Health' (WHO/CTD/WHOPES 97.1).
If a product does not meet PAHO quality criteria, it will be returned to the supplier. In such cases the supplier will be responsible for costs associated with the product return.
