New USP Chapters on Storage and Distribution under Way - but what is the Relevance?

The Pharmacopoeial Forum 40(2) presents the five new General Chapters on Storage and Distribution. In June 2014, the USP announced under "Compendial Updates" that the deadline for comments on these General Chapters would be extended to the end of August 2014. It concretely addresses the following 5 General Chapters:

  • <1083> Good Distribution Practices
  • <1083.1> Quality Management System
  • <1083.2> Environmental Conditions Management
  • <1083.3> Good Importation and Exportation Practices
  • <1083.4> Supply Chain Integrity and Security

These new chapters are supposed to replace the current ones <1079> and <1197> on storage and transportation of medicinal products and pharmaceutical excipients.

An essential prerequisite for the right storage and correct transport lies in the selection of an appropriate packaging system which ensures the necessary protection for the medicinal product; like, for example, desiccants or packaging materials which protect against light. The pharmaceutical packaging has to comply with the protection requirements of the material or product. Also the environmental influences (temperature, rel. humidity, etc.) have to be considered to enable transportation and storage of the medicinal product without any essential loss of quality.

You can find the complete text about the deadline extension as well as the five chapters on the USP website. Now it will be interesting to see which proposals will be incorporated into these new chapters to be published in one of the next editions of USP/NF. 

The stakeholders involved in the global supply chain need clear guidance on what measures need to be implemented to ensure a secure transport and storage of medicinal products. But what is the relevance of the USP chapters when they are finalised? FDA normally refers to the USP and even enforces USP standards. However, USP standards above the number 1000 (as it is the case with the GDP chapters described above) will not be enforced but are considered to be state of the art. In Europe the EU Commission has publised a GDP Guideline which is more concrete and is the official basis for GDP Inspections. The GDP Guide is already available in 22 different languages. The USP chapter might therefore cause confusion about what is expected for those companies dealing with products for the EU and US market. Harmonisation in the field of GDP is needed to make sure that standards are the same and that enforcement can be performed by using one uniform standard.

Source: USP

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