PAT & QbD SUPPLEMENT


FLEXIBLE PROCESSING ASSURES PRODUCT QUALITY


Mark Morton Consultant, Phoenix Scientific Services


Quality by Design (QbD) is currently attracting interest because of the co-ordinated regulatory framework that encompasses a series of documents issued by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). These documents seek to supplement the FDA’s Federal and EMA’s European regulations by integrating best development harmonised practices1-3


with new technologies4 to


ensure greater quality throughout the development and manufacturing lifecycle. As drug development can take many years to deliver a completed formulation ready for administration to a patient, the opportunity to apply structured design principles, risk analysis and novel technologies, which can enhance the quality, safety and efficacy, is significant.


The recent announcement that the FDA and EMA are to collaborate on a pilot project5


using


QbD has fuelled interest in this subject, and stimulated scientists working in Pharma to use QbD to develop scientific techniques for improving product quality, and promoting commercial opportunity.


The value of QbD In 2001, the manufacturing costs of the top ten Pharma companies comprised 36 per cent of


www.europeanpharmaceuticalreview.com


“Cost pressures have increased with many manufacturers


increasingly finding the operating environment more challenging”


their total operating expense, with forty five billion dollars6


consisting of the values of raw


materials alone. Since then, cost pressures have increased with many manufacturers increasingly finding the operating environment more challenging. The reasons for this are complex,


but mega-mergers, reduced pipeline output, spiralling research and development costs, the expiry of ‘blockbuster’ patents and increasing number of patent challenges from generic companies in the US are significant contributors. In this environment it is natural to


review manufacturing operations to seek efficiency savings, whether personnel, equipment or material. The new guidelines issued by the FDA and EMA allow risk based regulatory decision making and application of QbD principles to gain greater understanding. In certain circumstances this also provides the opportunity to improve cost-effectiveness and reduce expensive manufacturing errors and post approval submissions. Applying QbD principles within a cost efficient environment can avoid such problems as the decisions about supply can be based on scientific knowledge. As part of the risk mitigation strategy, a candidate material is checked for its chemical


European Pharmaceutical Review 13 Volume 16 | Issue 3 | 2011


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