Pharmaceutical companies are wrestling with how to address the differences in country-specific regulatory requirements for shipping of their products, particularly regarding the allowance for minor excursions from the labeled storage conditions.
Regulatory agencies worldwide are expressing a greater interest in the shipping practices pharmaceutical companies are using, and they want to see the stability data to support these practices. However, the conclusions they are drawing and the relevant policies and regulations they are applying differ, creating challenges for industry in bringing current science consistently into practice.
The challenges that firms have in dealing with various regulatory authorities on shipping requirements and excursions were highlighted by Merck Senior Stability Coordinator Rebecca Gentile at the PDA Cold Chain Management conference in Bethesda, Maryland in March.
“We have definitely noticed in the past years that there has been increased regulatory interest worldwide in shipping practices, most specifically in Latin American countries,” Gentile emphasized.
Some of these countries are open to scientific justification for a qualified shipping temperature range outside of the label storage conditions, as long as there is appropriate stability data on shipping qualification, she pointed out. “The information typically needs to be filed with the applicable product licenses or as an update to the license.” However, “other countries are still strictly requiring shipping only within the label storage conditions” (see box below).
[The regulatory challenges pharma companies are facing regarding the control/stability of products during shipping and the solutions being advanced are explored for subscribers here. Included are case studies of Merck’s experience in Latin America and a review of PDA’s current projects to further the quality of temperature-sensitive products during distribution. The full story can be purchased for $195 by contacting Peter Blachly (Peter@ipq.org). For subscription/license information, click here.]
See the following recent related stories:
“Stability Budget” to Assure Quality During Drug Distribution Proposed by PDA Task Force with ICH Adoption in Mind