Canada is a global life sciences and biopharma hub, playing host to no fewer than 390 pharmaceutical and 400 biotech companies, all of which will be relying more heavily on temperature controlled distribution in the future, research suggests.
The need for regulation in this area is growing with the proliferation of biopharmaceuticals, and previous evidence from Health Canada has suggested industry in the past was not willing to drive the change itself.
Sarah Skuce, compliance specialist at the drug GMP inspection unit compliance and enforcement coordination division, writing for Pharmaceutical Outsourcing, called attention to a survey conducted in 2003 which outlined that just a small fraction of companies were making efforts to monitor their distribution processes.
"By these results, it was apparent that there was need for additional guidance to ensure the requirements of the Canadian Food and Drugs Act and Regulations and their interpretations pertaining to storage and transportation were clearly articulated," Skuce said.
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More recently, research carried out by Thermal Packaging Solutions and Brigham and Women’s Hospital found instances of wholesale drugs reaching the hospital in a condition that left the medication vulnerable to exposure outside its recommended temperature limits, PMPNews.com reported.
This was found to be down to an "audit gap" in the distribution between the manufacturer and the hospital, with too little emphasis being placed on the packaging and procedure surrounding temperature controlled distribution.
In the past it would seem then that not only has too little priority placed on not just improving temperature controlled distribution, but also the joined-up approach needed across the industry to ensure good practice is followed.
Health Canada's latest guidelines, GUI-0069, came into force on April 28th 2011, superseding that released in October 2005.
The update brought with it a number of new obligations covering the jurisdiction of Health Canada, the mandated written agreements between regulatory bodies and transportation providers, and the parties involved in distribution.
The guidelines are clear in another key point; the responsibility for maintaining temperature controlled conditions is the job of all, from the pharmaceutical company in question to "fabricators, packagers/labellers, testers distributors, importers, and wholesalers".
Much of the focus of these new guidelines is in improving monitoring, recording and supervision of existing good practice in the field of temperature controlled distribution, rather than imposing new obligations.
Health Canada is also clear in its view that excursions can occur when even the most care is taken, and rather focuses on the correct procedures to overcome this. In theory, this should improve the reporting of excursions.
"Temperature excursions outside of their respective labelled storage conditions, for brief periods, may be acceptable provided stability data and scientific/technical justification exist demonstrating that product quality is not affected," the guidelines state.
With regard to documentation, the guidelines require a written agreement between the regulatory party and carrier, the maintenance of records of inbound and outbound shipments – kept for a period of one year after the expiry date of the product – and a record of any action taken after excursions.
Records of temperature monitoring data must be kept, with the guidelines adding: "Monitoring of storage facilities is conducted at points representing the worst case scenarios of the temperature range based on temperature mapping."
In short, Health Canada's guidelines are focused on ensuring the process for temperature controlled distribution is not a series of disparate tasks – and certainly not simply a compliance exercise.
The additions introduced in GUI-0069 build on the good practice that has formed around the distribution of temperature controlled pharmaceuticals in recent years, in part as a result of the greater emphasis being placed on the growing biopharmaceutical and life sciences industries.
The message is clear; from the manufacturer to the wholesaler, temperature controlled distribution and storage should be at the top of the agenda.
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