QbD: new Guidance from EMA and FDA

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QbD: new Guidance from EMA and FDA

The European Medicine Agency (EMA) and the U.S. Food and Drug Agency (FDA) have published a joint question-and-answer document that provides further guidance on the quality-by-design concept. Read more.

http://www.gmp-compliance.org/ecanl_654_0_news_4015_8280,8356,Z-PDM_n.html

The Quality by Design (QbD) concept has been introduced by the International Conference on Harmonisation (ICH) document  Q8, supported by Q9, Q10 and also Q11. In the meantime it is well-known within the pharmaceutical industry. However many companies still struggle with the implementation. Both the European Medicine Agency (EMA) and the U.S. Food and Drug Agency (FDA) are supporting the pharmaceutical industry in the employment of the paradigm. Now, EMA and FDA have published a second joint question-and-answer document that provides further guidance on the quality-by-design concept.

The new document focuses on ‘design space verification’ and reflects conclusions reached in the on-going parallel assessment, which was launched in 2011. The objective of the parallel assessment is to share knowledge, facilitate a consistent implementation of the international guidelines on the implementation of the quality-by-design concept and promote the availability of medicines of consistent quality throughout the European Union (EU) and the USA.

The EMA and the US FDA will publish further conclusions on other quality-by-design-related topics as the pilot programme continues and more parallel assessments are conducted.

Source: EMA press release

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_detail_001941.jsp&mid=WC0b01ac058004d5c1

04/11/2013

European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach

The European Medicines Agency (EMA) and the United States Food and Drug AdministrationExternal link icon (US FDA) have published a second joint question-and-answer document that provides guidance on the quality-by-design concept.

Quality-by-design is a science and risk-based approach to pharmaceutical development and manufacturing. It involves designing and developing pharmaceutical formulations and manufacturing processes to help ensure product quality; these concepts are described in the international guidelines ICH Q8, Q9, Q10 and Q11.

The document published today focuses on ‘design space verification’, a demonstration that the combination of the process parameters and material attributes established at pilot scale during pharmaceutical development are capable of delivering a product of appropriate quality on a commercial scale.

In March 2011, the EMA and US FDA launched a three-year pilot programme for the parallel assessment of certain quality or chemistry manufacturing and control (CMC) sections of applications that are relevant to quality-by-design. With the agreement of the applicants, experts from the Japanese Pharmaceuticals and Medical Devices AgencyExternal link icon (PMDA) participate as observers in the programme.

The objective of the parallel assessment is to share knowledge, facilitate a consistent implementation of the international guidelines on the implementation of the quality-by-design concept and promote the availability of medicines of consistent quality throughout the European Union (EU) and the USA.

The question-and-answer document published today reflects the conclusions reached by the EU and US regulators on the specific topic of design space verification as part of their parallel assessment.

The EMA and the US FDA will publish further conclusions on other quality-by-design-related topics as the pilot programme continues and more parallel assessments are conducted.

The pilot programme is open to selected procedures, including applications for initial marketing authorisations, type-II variations and scientific advice. Participation in the pilot is voluntary. Interested applicants and sponsors should notify both agencies three months prior to submission of an application.

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