Less batch failure. It mainly Additional opportunities: An enhance QbD approach to pharmaceutical development provides opportunities for more flexible regulatory approaches. 8. 4. Organizational learning is an investment in the future. 7. Empowerment of technical staff. approaches of QbD, FDA, EMA or PMDA. Recently the concept of “Quality by Design” (QbD) gaining much attention among pharmaceutical industries for maintaining Quality. Eliminate batch failures. REGULATORY VIEWS ON QBD There were several EMA marketing authorization applications (MAA) with QbD and PAT elements for the following products: Avamys®, Torisel® , Tyverb® , Norvir® , Exjade® , Revolade® , Votrient® , etc.). Pharmaceutical Industry has about the nature of new trends in pharmaceutical development and manufacturing: the concept known as Quality by Design (QbD), it also discusses some of the interesting angles on this new concept. Better development decisions. Regulators/Industry QbD Workshop January 29, 2014 London, UK ... • Allow EU and US assessors exchange their views on the implementation of ICH Q8-10 using actual applications and facilitate harmonisation ... will be a global benchmark for regulation of pharmaceutical quality. These documents organize and demonstrate process knowledge and understanding. 21 Avoid regulatory compliance problems. Benefits of QbD 1,3,5,6 1. Title: Quality by Design QbD A Modern System Approach to Pharmaceutical Development and Manufacturing FDA P 1 Quality by Design (QbD) A Modern System Approach to Pharmaceutical Development and Manufacturing FDA Perspective Moheb M. Nasr, Ph.D. CDER, FDA MOHEB.NASR_at_FDA.H QbD is good Science. REGULATORY AGENCY AND INDUSTRY VIEWS ON QBD Industry Regulatory Agency Integrate across business units(e.g. Reviewers still need a lot of time to assess the QbD approach and we tend to ask more questions than with the traditional approach. Minimize deviations and costly investigations. chemist,engineer,statistici ans) Incorporate multidisciplinary CMC review(e.g. Return on investment / cost savings. More efficient and effective control of change. R&D, manufacturing quality) Integrate review inspection and compliance Integration across disciplines (e.g. The Pharma Industry is disappointed about what FDA and ICH hinted as a benefit of QbD (Quality-by-Design) — Regulatory Flexibility. Current views on the implementation of QbD in the development of Generic Drugs are also captured in this article in an attempt Advantages of QbD. QbD is good Business. Regulatory actions, especially post approval change actions, might be a little different because the regulatory framework of each regulatory agency is different. 2. It serves as a bridge between industry and drug regulatory authorities to move towards a scientific, risk based, holistic and proactive approach for development of pharmaceutical product. •QbD can be applied to legacy and new products, but the supporting document package may differ. 5. 3. Opportunities 8,9 1. •QbD is a quality system that builds on past and sets future regulatory expectations •QbD can be viewed as a process defined by series of document requirements. Benefits for Industry: Better understanding of the process. Regulatory Assessment of Applications Containing QbD Elements -FDA Perspective Industry feedback has focused on the use of prior knowledge and risk analysis Intended to illustrate the types of development studies ANDA applicants may use as they implement QbD Yet, unclear QbD and regulatory expectations do exist, so industry will have to work closely with the FDA to fulfill the spirit of QbD inline with the FDA’s current thinking. 6. 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