Stability skimping a frequent component in FDA warnings

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WOBURN, MA--Behind every drug expiration date is stability testing and, it is hoped, a stabilitarian--one who coordinates the functions that contribute to determining drug stability.

"Stability is a frequent source of FDA Form 483 inspection observations and warning letters," said presenter John O'Neill at last night's Parenteral Drug Association New England chapter meeting. "Support your local stabilitarian."

Not all stabilitarians need support, he said in an interview after the meeting. Some companies staff the stability test function well and regard it as a key process step in drug development and manufacturing. Others--especially in these economic times--decentralize it, with the belief that the job "can be done by a sharp analyst working on a project team," he said. "Sometimes it can."

O'Neill himself recently experienced just such decentralization. He was laid off in December from Boston Scientific ($BSX) after 5 years as corporate steward for shelf life quality. He boasts 30 years experience in stability operations in the pharma and medical device industries.

Stability is the degree to which a product remains within established specs at established conditions and shelf life. Stability liabilities include temperature, humidity, photostability, mechanical action (shaking), chemical interactions and irradiation. Stability tests are run on excipients, API, packaging, intermediates, bulk production, sterilized and finished product.

When overseers at the U.S. National Drug Stockpile decide to extend the shelf life of expired Tamiflu to boost supplies during a drug shortage--as happened in 2009--it's only after FDA stabilitarians have tested stockpiled samples to make sure the drug is still within spec and accelerated aging tests indicate the drug will remain in viable condition for another two years. 

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