Promoting quality in drug manufacturing
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As pharmaceutical manufacturing evolves from an art form to a science-based process, the US Food and Drug Administration (FDA) is eyeing opportunities to obtain better information on products that will justify more risk-based regulatory review and inspection policies. The overriding goal is to apply a “quality by design” approach to pharmaceutical manufacturing to achieve the “desired state” of product quality and performance, explained Ajaz Hussain, deputy director of the Office of Pharmaceutical Science (OPS) in FDA’s Center for Drug Evaluation and Research (CDER). He and others outlined a number of steps FDA is taking to encourage more rational pharmaceutical development and manufacturing systems at the July meeting of FDA’s manufacturing subcommittee of the advisory committee on pharmaceutical science. If a manufacturer can demonstrate a good understanding of key product attributes (that is, stability and bioavailability) and provide evidence that it can control critical variables and detect product deviations, regulatory authorities will be able to review applications in one review cycle, permit improvements in a manufacturing process without prior approval, and implement a risk-based inspection process, explained Pfizer vice president John Berridge. To achieve such an ideal situation, FDA is taking steps to re-engineer its chemistry, manufacturing and controls (CMC) review process in new drug applications (NDAs) and abbreviated NDAs (ANDAs) for generic drugs. Prime goals are to curb multiple review cycles, reduce application resubmissions and eliminate the need for prior approval of most manufacturing supplements. At the same time, FDA is working with other regulatory authorities and manufacturers to gain agreement on new standards for submitting drug quality information in the common technical document (CTD) developed by the International Conference on Harmonization (ICH). Streamlining CMC reviews The current CMC review system is resource intensive, discourages manufacturers from making improvements in approved products and imposes unnecessary regulatory burdens on industry, observed Moheb Nasr, director of CDER’s Office of New Drug Chemistry (ONDC) in OPS. He cited a number of factors for this unfortunate state: ONDC reviewers evaluate all Source : accessmylibrary.com |