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Quality by Design

Vaccines Conference in Belguim, 4th - 5th December 2013

Quality by Design

Pharmaceutical Manufacturing China 2012

Pfizer project is quality-by-design milestone for FDA and EMA

Pfizer
Pfizer's marketing authorisation applications will allow the regulatory agencies to assess the parts of the applications related to QbD in parallel

A pilot project set up earlier this year to encourage the adoption of quality-by-design in pharmaceutical manufacturing has passed its first milestone, with the first parallel application now filed with regulators on both sides of the Atlantic.

Quality-by-design (QbD) is a concept in which the quality aspects of a production process and the resulting product are intended to be built-in from the start, based on a clear understanding of the process and the use o

Quality by Design - the new manufacturing paradigm

Published on 31/05/11 at 07:30am
Huw Kidwell
Pharmaceutical pill manufacturing
QbD, along with other new methods and technologies, is slowly transforming pharma manufacturing

Pharmaceutical manufacturing currently operates using processes that are widely seen as inefficient, inflexible and outdated.

In the current system of ‘batch processing’ product quality is tested at numerous staging posts in the manufacturing process.

FDA and EMA join forces on quality-by-design

The FDA has teamed up with the EMA on a new pilot programme that will allow parallel evaluation of marketing applications incorporating elements of quality-by-design (QbD) from 1 April.

QbD is a concept in which the quality aspects of a production process and the resulting product are intended to be built-in from the start, based on a clear understanding of the process and the use of a well-defined risk-management strategy.

The basic tenets of QbD are laid out in the ICH Q8, Q9 and Q10 documents developed by the International Conference on Harmonization.

Tablet Process Development, Validation and the application of QbD

Integrated Tablet Formulation Development

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