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Define omnipresence3/11/2023 However, owing to the involvement of active drug substance(s), multiple functional/nonfunctional excipients and manufacturing processes that lack automation, pharmaceutical products are facing a high degree of variability in their quality, which has become a major topic of debate. Introductionįor decades the pharmaceutical industry has been continuously engaged in developing new drug products and generics to cater for healthcare demands and serve the patient community. This article endeavours to provide an overview on vital precepts of QbD paradigms during different stages of development for efficient pharmaceutical manufacturing to produce a robust product with the desired safety and efficacy. Regulatory agencies are encouraging the pharmaceutical industry to holistically implement QbD in all of these stages to reduce product development times, and accelerate regulatory review and approval processes. QbD has brought enormous benefits to the development of drug substances, analytical methods, dissolution testing, stability studies, bioequivalence testing and clinical trials. ![]() This has certainly revolutionised traditional testing-intensive pharmaceutical manufacturing. With the ascent of time, a series of guidances have been published by ICH and endorsed by the FDA for harmonising the holistic implementation of QbD paradigms in pharmaceutical manufacturing. ![]() QbD does not just facilitate product and process understanding, it also increases regulatory flexibility, enabling faster approval of products with reduced numbers of recalls and rejects.
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