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Quality by Design is Essential in the New U.S. Regulatory Environment

    Quality by Design is Essential in the New U.S. Regulatory Environment

    The United States Food and Drug Administration (FDA) has challenged the pharmaceutical industry to achieve a level of process understanding consistent with controlling process variability and assuring product quality in “real-time” while a batch is being manufactured (RTQA). Ideally, the appropriate level of quality must be assured by the process in real-time despite variations in materials and processing. In the past, such variations would have resulted in unacceptable product batches that were prevented from entering the market only by laboratory testing of the finished product.  In other words, the ability to achieve the appropriate quality outcome must be designed into the process itself rather than relying on final product testing.

    This increased emphasis on “Quality by Design” (QbD) requires pharmaceutical manufacturers to make larger investments earlier in the product life cycle during process development in advance of approved commercial operations. The goal is to develop a sound scientific basis for a “Control Space” that accommodates a range of defined variability in the commercial process materials and operations and still produces the right product quality outcomes.

    It is expected that companies who adopt QbD, together with a quality system as described in the draft International Conference on Harmonization (ICH) Q10 document, “Pharmaceutical Quality Systems,” will achieve this “desired state” of pharmaceutical manufacturing.

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