Pfizer project is quality-by-design milestone for FDA and EMA
pharmafile | June 21, 2011 | News story | Manufacturing and Production |Â Â EMA, FDA, Quality by Design, pharma manufacturing newsÂ
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 of a well-defined risk-management strategy.
The European Medicines Agency set up the three-year pilot programme earlier this year with the US FDA to allow the parallel review of certain development and manufacturing data components, particularly the quality/chemistry, manufacturing and control (CMC) section of marketing applications.
The first application is from Pfizer and the EMA said the two regulatory agencies “will communicate with and consult each other regularly during the evaluation process, resulting, if possible, in a common list of questions to the applicant and harmonised evaluation of the applicant’s responses”.
The pilot came about because of concerns that the principles underpinning QbD – enshrined in the International Conference on Harmonization (ICH) documents Q8, Q9 and Q10 – were being interpreted differently in the USA and Europe.
A primary objective is to remove any uncertainty about how regulatory authorities will respond to applications containing QbD elements and encourage more widespread adoption by the drug industry.
As a result, it is hoped that pharma can move away from the current approach of batch manufacturing, process revisions and ‘snapshot’ testing in favour of a production approach based on continual monitoring and refinement of processes.
The pilot programme applies to New Drug Applications and Marketing Authorisation Applications, some dietary supplements, and CMC meeting requests that include QbD elements submitted to both agencies at about the same time.
The pilot will only include chemical entities and not biologic products and is scheduled to end on 31 March, 2014.
Phil Taylor
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