Survey on implementation of ICH Q8, Q9 and Q10 Guidelines
Participate and know how QbD is running in ICH zones.
We are working with an American magazine specialized in the pharmaceutical sector, to write an article on the implantation of Quality by Design in Europe. In order to obtain updated data, we have designed a survey that will have international diffusion. It is oriented to know the implantation degree in pharmaceutical companies of ICH Q8, Q9 and Q10 Guidelines.
The survey is totally anonymous since it is housed in a web that only registers respondents IP directions to avoid multiple answers. The name and company of the respondent does not appear, he is only asked about generic company information (API, drugs, size etc) to be able to derive correct conclusions
The aim is to obtain data on the current implantation in pharma companies of the practices recommended by ICH Q8, Q9 and Q10 Guidelines in subjects like the use of the design of experiments during the development, the statistical process control and the use of PAT tools, the risk management and in general about the elements of quality systems.
We encourage people involved in QbD projects to participate, regardless of the company size or the degree of implantation of the QbD initiatives.
The results will be published as a benchmarking exercise and will provide the base to compare the situation between USA and Europe and to understand differences in regulatory approach between FDA and EMEA.
Below you can find the link to the survey. Please, forward to people in your company who can provide relevant information. Click and follow instructions:
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