UNICEF supplies pharmaceutical products to many countries world-wide, including those that have little or no regulatory control of the products supplied. UNICEF is therefore committed to evaluate the quality of the products supplied by UNICEF. All suppliers are pre-qualified before being entered in our supplier database, and invited to bid. This involves site visits to confirm Good Manufacturing Practice (GMP). All supplier products are technically approved as part of the bid adjudication process. All deliveries of pharmaceuticals to our warehouse are subject to quality control measures. UNICEF Supply Division and the warehouse has Good Distribution Practice (GDP) certification.
UNICEF mainly supply pharmaceutical products listed in the World Health Organization’s (WHO's) Essential Medicines List www.who.int/medicines/ (WHO technical report series). The pharmaceutical products (essential medicines) available from the Copenhagen warehouse are listed in the Supply Catalogue.
UNICEF normally buys directly from manufacturers.
The UNICEF Quality Assurance System for Pharmaceuticals covers the following aspects:
WAREHOUSE - GOOD DISTRIBUTION PRACTICE
The UNICEF Supply Division warehouse in Copenhagen is the only UNITED NATIONS warehouse, which is licensed to wholesale pharmaceutical products. UNICEF Supply Division is licensed to wholesale pharmaceutical products in accordance with the European Community Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C63/03). The licence has been given by the Danish Medicines Agency (under the Ministry of Health).
THE ORGANISATION OF UNICEF
There is a total split of responsibility between those who perform the overall assessment of the quality of the pharmaceutical products and those who are responsible for the purchase of them.
GENERAL PHARMACEUTICAL INFORMATION
All suppliers must complete a copy of the UNICEF Technical Questionnaire for Pharmaceutical Manufacturers.
GOOD MANUFACTURING PRACTICE
UNICEF Supply Division purchases only from manufacturers with a proven record of competence, knowledge and experience.
Both APIs and FPPs must be manufactured as per GMP guidelines established by WHO. (Ref: WHO Geneva, 2007.Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials. Volume 2, 2nd updated edition or latest edition) http://www.who.int/medicinedocs/index/assoc/s14136e/s14136e.pdf
The manufacturer must forward a copy of the Manufacturing Licence for the pharmaceutical products issued by their National Health Authority. Alternatively a GMP certificate stating the dosage forms manufactured may be submitted.
UNICEF approves the site of manufacture for each product supplied by UNICEF.
UNICEF requires that all suppliers permit UNICEF, or any other representative as may be designated by UNICEF, to have access to the manufacturing facilities of the goods at all reasonable times to inspect the manufacturing site and processes for the production, quality control, quality assurance and packing of the goods. The Manufacturer shall provide reasonable assistance to the representative for such appraisal, including copies of any documentation as may be necessary. UNICEF reserves the right to reject any material, which does not conform to the required specification.
All suppliers are included in the UNICEF program for GMP inspection. All suppliers are normally inspected every 2 – 5 years depending on the regulatory environment in the country of origin.
The GMP inspection may be carried out in conjunction with the National Health Authority. However, UNICEF does not issue GMP licences nor GMP certificates following these GMP inspections.
UNICEF work in close collaboration with WHO Geneva and other international organisations / NGO’s.
UNICEF is also a Partner to the Pharmaceutical Inspection Cooperation Scheme (http://www.picscheme.org).
In cases where UNICEF receives a copy of a GMP inspection report issued by one of the collaboration partners UNICEF may choose to waive the requirement to perform it’s own GMP inspection
GENERAL PRODUCT INFORMATION
All suppliers are as part of our tender process requested to complete a Product Questionnaire for each product they supply to UNICEF.
The product is approved based on the information provided in the Product Questionnaire and the technical documentation submitted.
Detailed requirements in relation to, but not limited to:
• Marketing Authorization in the country of origin
• WHO-certificate “Certificate of Pharmaceutical Product”
• Product specification reference to international recognised Pharmacopoeias
• Labels and packaging inserts
• Shelf life and storage
• Pharmaceutical equivalence
• Active Pharmaceutical Ingredients and Excipients
can be found in UNICEF Technical Requirements for Pharmaceutical Products.
CERTIFICATE OF ANALYSIS
Certificate of analysis from manufacturer's own quality control laboratory covering each batch delivered to UNICEF are to be submitted along with the product as well as the shipping documents.
Each shipment is assessed by the independent Quality Control in UNICEF.
Samples are taken on a random basis and analysed at independent laboratories.
For manufacturers and suppliers:
UNICEF's Technical requirements for pharmaceutical products is now online.