14/15 December 2021
With the revision of the WHO Technical Report Series No. 957 in June 2010, the WHO has also updated Annex 5 "WHO good distribution practices for pharmaceutical products".
The scope and objectives have been expanded to all aspects of the distribution process and the complete supply chain. These aspects now include, but are not limited to, procurement, purchasing, storage, distribution, transportation, repackaging, relabeling, documentation and
record-keeping practices of pharmaceutical products (the principles for the distribution of starting materials like active pharmaceutical ingredients and excipients are not covered in this document). It is also the aim to set out appropriate steps to avoid the introduction of counterfeits into the marketplace via the distribution chain and to foster product security. Several chapters have been amended accordingly.
Also a new term has been introduced: Good Pharmacy Practice (GPP); the practice of pharmacy "aimed at providing and promoting the best use of medicines and other health care services and products, by patients and members of the public. It requires that the welfare of the patient is the pharmacist's prime concern at all times."
A new chapter "General Principles" has been implemented, defining that all parties involved in the distribution of pharmaceutical products have a responsibility to ensure that the quality of pharmaceutical products and the integrity of the distribution chain is maintained throughout the distribution process from the site of the manufacturer to the entity responsible for dispensing.
Training of personnel involved in distribution activities is described in more detail and the requirements do now correspond to GMP requirements, including written training programme and assessment.
Chapter 8.5 requires that the approval of a supplier and distributer should come from the competent authority of the individual country where the legal entity is registered.
Another new chapter deals with the traceability of pharmaceutical products, saying that "all parties involved in the supply chain should be identifiable, depending on the type of product and on national policies and legislation" and that "measures should be in place to ensure that pharmaceutical products have documentation that can be used to permit traceability of the products throughout distribution channels from the manufacturer/importer to the entity responsible for selling or supplying the product."
It is also pointed out that "unless there is an appropriate alternative system to prevent the unintentional or unauthorized use of quarantined, rejected, returned, recalled or suspected counterfeit pharmaceutical products, separate storage areas should be assigned for their temporary storage until a decision as to their future has been made." This is also to avoid confusion and to prevent distribution until a decision has been taken with regard to their disposition. The particular storage conditions applicable to a pharmaceutical product which is rejected or returned should be maintained during storage and transit until such time as a decision has been made regarding the product in question.
Where third-party carriers are used, distributors should develop written agreements with carriers to ensure that appropriate measures are taken to safeguard pharmaceutical products, including maintaining appropriate documentation and records.
You can find a comparison of the new Annex with the previous version in the ECA Members Area.
On behalf of the European Compliance Academy (ECA)