Inspection and Receipt

When receiving shipments of health products, the following verifications should be carried out by UNDP CO (and a national reception committee, if applicable):

• Visual inspection: Containers and products should be visually inspected for possible contamination, tampering and damage (see Annex 2 in Guidance for UNDP Country Offices on Health Products Quality Assurance in the Supply Chain). Damage to containers and any other problems that might adversely affect the quality of the material should be recorded and investigated.
• Conformity of received items with the specifications of the purchase order: item description; item code (if applicable); strength; dosage form; packaging and labelling
• Quantities delivered versus quantities ordered
• Integrity of packages and seals
• Presence of certificates of analysis, one for each batch number received, and presence of the Certificate of Pharmaceutical Product (in WHO recommended template) if required by the NRA.
• Reading and analysis of temperature conditions during transport and transit (dataloggers’ readings) – see details further below.
• Verification of remaining shelf life (RSL) – should be “at or above” the minimum RSL agreed with the supplier.

A receiving report should be completed by UNDP CO (or the reception committee, if applicable) upon each delivery. The report and the annexes (COAs, CPPs) should be archived and kept available for retrospective controls by the PR or other relevant entities (e.g., UNDP QAS Team, NDRA). If there is national reception committee, the following entities should ideally be represented in this committee: UNDP CO, NDRA, relevant disease programme (e.g., HIV national programme for reception of ARV medicines), Central Medical Stores (CMS) or other entity in charge of central storage, and the Global Fund Principal Recipient (PR), in case UNDP CO is the procurer for another PR. GFPHST issued a Standard Operating Procedure (SOP) for Inspection and Receipt of Health Products to guide UNDP COs during these activities.

Handling of dataloggers at reception

UNDP COs are responsible to ensure that the dataloggers in the shipments are retrieved, data are read, analyzed and kept as record with the reception report.

Any significant deviation observed (temperature excursion) during transportation should be immediately reported by UNDP CO to the GHPC HPS, QAS, and HPMS focal points. The GHPC QAS team will coordinate with the supplier to obtain information on the appropriate actions to take. This could lead to the replacement of the products if the supplier’s assessment is that the quality of the products cannot be guaranteed. “Significant” deviations include:

If issues of non-conformity or quality are observed at reception:

• UNDP COs must ensure that the rejected products are either put in quarantine (if further investigation is needed) or categorized as rejected products (if rejection is final). The supplier(s) must be informed in writing as soon as possible in order to initiate any needed investigation and/or resolve the dispute.

• Rejected products: Stringent precautions should be taken to ensure that rejected health products cannot be used. This can be achieved through separate storage or by means of a validated computerized system. Rejected products may be destroyed or be returned to the supplier.

• UNDP CO should obtain a written statement from the suppliers about the actions to take (destruction in the recipient country, resending of remaining quantities) and the compensation for the expenses caused.