Supplies and Logistics

Quality Assurance- Pharmaceuticals and Nutrition

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With rare exceptions, all UNICEF procurement of pharmaceutical and nutrition products must be carried out by Supply Division. Without their own dedicated pharmacists, UNICEF field offices are not allowed to procure such sensitive products.

This allows UNICEF to ensure the quality of drugs and therapeutic food centrally, using a team of qualified quality assurance staff that includes experienced pharmacists.

Compliance with standards
The team is also responsible for the approval of all manufacturers of pharmaceutical products, who have to comply with the Good Manufacturing Practice (GMP) guidelines issued by the World Health Organization (WHO). Further information on WHO GMP Guidelines can be found on www.who.int/medicines.

Manufacturers of nutrition products (mainly Ready-to-Use Therapeutic Food) have to comply with applicable Hazard Analysis and Critical Control Point (HACCP) guidelines as issued in the Codex Alimentarius as well as ISO 22000.

Compliance with these guidelines is ensured through the pre-qualification of the manufacturers, which also includes regular UNICEF GMP inspections of the manufacturing sites involved.

Goods Receipt Inspection is carried out at our warehouse in Copenhagen. Pharmaceutical products received are sampled and checked for compliance to the specification. Random samples of pharmaceutical and nutrition products are sampled in accordance with an annual test plan and forwarded to an external accredited laboratory for analysis.

Direct shipments of pharmaceutical and nutrition products may be subject to Pre-Delivery Inspection and analytical testing to ensure compliance with the specifications.

Good Distribution Practice
The UNICEF Supply Division warehouse in Copenhagen is Good Distribution Practice (GDP) certified. The certification is carried out by the Danish Health and Medicines Authority based on regular GDP inspections of the UNICEF warehouse.

The certification ensures that pharmaceutical products are handled appropriately and are traceable at any time.

Any complains or recalls for pharmaceutical and nutrition products are handled by the QA pharma team, which also handles all import and export authorisations for narcotic products.

Pharmaceutical Inspection Co-operation Scheme
UNICEF is a partner to Pharmaceutical Inspection Co-operation Scheme (PIC/S). The UNICEF - PIC/S Co-operation agreement was renewed in 2013 and is valid to May 2016. PIC/S' mission is "to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products."

Further information about PIC/S can be found on www.picscheme.org.

Further information can be obtained from Quality Assurance Specialist: Peter Svarrer Jakobsen: pjakobsen@unicef.org


 

 

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