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Volume 5, Issue 1
January 17, 2006 |
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In fact, they are often used interchangeably, and this inconsistency leads to significant confusion, reports Rafik Bishara, chairman of the Pharmaceutical Cold Chain Discussion Group (PCCDG), Parenteral Drug Association, in a recent paper. Adopting a consistent use of those terms is a recommendation PCCDG has made in a guidance document that describes essential principles and practices for developing packages and systems that protect temperature-sensitive products. The recently published document - technical report 39 - represents an industry consensus on "what is doable, what is practical, and what works," says Robert Seevers, PCCDG member, and principal regulatory scientist, Eli Lilly & Co. "This guidance addresses what a company needs to do to provide the best reasonable assurance that a temperature-sensitive product will maintain its quality as it goes through the transportation environment and how to assess any temperature excursions that might happen," Seevers says. The report references the United States Pharmacopeia's (USP) 1079 guidance document on good storage and shipping practices published in 2004. Document "1079 is considerably more prescriptive. It talks more about the 'how' in addition to the 'what,' says Seevers. In addressing storage of samples by sales representatives in automobiles, for example, 1079 says monitors should be used in trunks and passenger cabins for deriving mean kinetic temperatures, and environmentally sensitive drugs should be removed from autos at the end of three days. PCCDG however is working to prepare its own more specific guidance in a second technical report based on a master validation plan currently being developed. The validation plan will be "a consensus list of best industry practices, for validating and qualifying components of the transportation process," Seevers says.
Seevers and Bashira will participate in a PDA-sponsored Web conference on technical report 39 on Valentine’s Day (February 14). And the report will be featured at a PDA-sponsored cold chain conferencein Bethesda, MD, March 27-28. Another PCCDG goal will be to harmonize efforts with those of other countries. In November, Canada issued rules that companies have to produce contracts they have with carriers and document that proper care is followed in cold chain shipping. Europe’s Cold Chain Committee now requires that cargo has to be transported within products' labeling guidelines. U.S. and European guidance differ somewhat, for example, in the area of temperature excursions. Europe puts more emphasis on how they can be prevented, where in the United States the focus has been on the extent they affect the quality of the product, Seevers says. PDA and USP are issuing guidance and standards that have been largely absent, as there are no federal regulations covering cold-chain shipping. "FDA has not provided guidance in this area. But they have become very interested in it recently," says an industry source. "For a long time, drug firms and FDA have tacitly agreed that good manufacturing practices end when you get to the loading dock and you put it in the truck," another industry source says. In policing cold-chain practices, FDA’s approach has been ‘tell us what you think makes sense, and then our function will be to see that you do that," this source adds. As companies pay more attention to their transport packaging requirements and to the real measurable challenges that packages face en route to their destinations, this expert guidance from PDA and USP is necessary and should be invaluable. To an ever-growing extent, companies will be compelled to meet standards, as they ship temperature-sensitive cargo to over seas markets. Market globalization, along with the growth in biotechnology and protein-based drugs, is projected to increase temperature-sensitive shipments from 8% today, to 20% or more by 2010. For the record, manufacturing processes are "validated," packaging is "qualified." Qualification provides a high degree of assurance that a process is replicable, while validation describes how a system will perform under highly controlled conditions, says Bishara. |
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David Vaczek
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Do you know what the terms "validation" and "qualification" mean when
they are applied to cold-chain packaging and transportation?
