U.S. Manufacturers Still Favor Three Batches in Process Validation
This article was originally published in The Gold Sheet
Despite FDA’s prodding to focus on the science and not the numbers, the pharmaceutical industry still favors a three-batch approach to process validation.
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Most pharmaceutical manufacturers are adopting or making plans to adopt the continued process verification approach outlined in FDA’s November 2011 process validation guidance, which will shine a light on their manufacturing processes. But not everyone is anxious to see what that light will reveal.
Readers of “The Gold Sheet” focused more on articles about data integrity than any other topic last year, which is a big reason why data integrity was the No. 1 story of 2014. A number of other highly read articles last year focused on additional topics that were also among the top stories in pharmaceutical manufacturing quality last year.
FDA’s final process validation guidance clarifies that legacy products, or products that are currently on the market, will be exempt from early stage process validation. The guidance also endorses the use of process analytical technology for monitoring product quality.