Regulators produce QbD report
pharmafile | August 28, 2013 | News story | Manufacturing and Production, Sales and Marketing | EMA, FDA, QbD
European and US regulators have published the first fruits of their collaboration on assessing measures to ensure drugs are manufactured to a high standard.
The EMA and FDA began their three-year pilot scheme in March 2011 to look together at the quality-by-design (QbD) elements of pharma companies’ marketing authorisation applications (MAAs), and to share thinking on regulatory issues.
The idea of QbD is to ensure predictable and pre-defined product quality, standardising such things as design and control of the manufacturing process and identification of key quality areas.
The method is built on using statistics and risk assessment methods to develop compounds, with the hope that QbD can make the chemistry, manufacturing and control (CMC) review of an abbreviated new drug application (NDA) into a precise, science-based quality assessment.
Implementing the QbD concept falls under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines Q8, Q9, Q10 and Q11 – there had been concerns that these were being interpreted differently in Europe and the US.
CMC is the main thing that the EMA and FDA are looking at, with a view to ensuring that drugs used in the European Union and US are of consistent quality, although the pilot will look at other QbD-related topics as it continues.
These include design space verification, the level of detail on design space and risk assessment that should be in submissions, continuous process verification and continuous manufacturing.
Although the industry is engaged with the concept, there have been concerns that QbD represents a major culture shift for pharma, with an attendant increase in time and money required for companies to make it work.
The pilot is voluntary for pharma firms and takes in MAAs and NDAs, type II variations/prior-approval supplements (sNDA) and scientific advice/CMC formal meeting requests that include QbD/Process Analytic Technology (PAT) elements.
It applies to drugs which are either submitted to both agencies at the same time or to them individually, in which case the other regulator will offer consultative advice.
The main findings from the collaboration so far include the suggestion that companies should provide Quality Target Product Profile (QTPP) information in applications in tabular form.
Others cover exactly how pharma firms should present Critical Quality Attributes (CQAs) in their applications.
The collaboration between the EMA and FDA has also thrown up issues over the ways in which different applicants employ various terms, such as ‘key’ when referring to critical process parameters.
The pilot is due to end in March next year.
Adam Hill
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