The World Health Organisation’s (WHO) New Draft Guideline

The WHO is looking for comment on its proposal to combine the features of good storage and distribution for medical products into a single guidance document and will be applicable to individuals and outlets involved in storing and distributing medical products.

It is relevant in every stage of the supply chain from manufacture to administration.

When completed, it will be valid for all medical products that patients can obtain with or without a prescription, including drugs, biologicals, vaccines and medical devices. It is relevant in every stage of the supply chain from manufacture to administration. Particular sections of the guideline may also be employed, by governments, regulatory bodies, international purchasing organisations, donor agencies certifying groups, healthcare employees and any other people involved in the supply chain.

The organisation advises on how the different stakeholders can execute their responsibilities and evade the introduction of inferior and unreliable products into the market. It believes that the principles of good storage and distribution practices should be incorporated in national law. The guideline gives advice on, among other topics, quality management, complaint management, stock control, personnel, maintaining documentation and inspection of storage and distribution facilities.

The final guidance should be presented for adoption at the WHO’s Expert Committee on Specifications for Pharmaceutical Preparations next meeting in October. 

Source: Medtech Insight (an Informa product)