Apart from clinical development pharmaceutical development is one of the key areas to be covered during drug development.
Result of pharmaceutical development is the physical product with dosage form and packaging after market approval.
A lot of aspects like chemistry, pharmaceutics, technology, manufacturing process at all scales, regulatory affairs, stability, quality control are to be considerd aside from a lot of others.
To consider these numerous impacts during pharmaceutical development is already a challenge as such.
However, this challenge changes to a know-how based interdisciplinary "art" of successful development, when complexity is getting even bigger by inclusion of other disciplines like clinical development.
Successful drug development is then mainly dependent on correctly set targets and efficiency of technological and organisational processes.
Following this consideration the ICH Q8 guideline "Pharmaceutical Development" was published.
It introduced terms like QbD (Quality by Design), DoE (Design of Experiments), QTPP (Quality Target Product Profile), CQA (Critrical Quality Attribute) and CPM (Critical Process Parameter). Most of these terms have been in use under different names already for years.
Combined with the requirements from ICH Q9 (Quality Risk Management) relations between the both guidelines can be easily detected e.g. by means of a RAMM (Risk Analysis and Mitigation Matrix). We are simply using MS-Excel for this purpose.
Transferring these methods into practice has proven to be a "bumpy" process. We'll show you how it works and demonstrate how simple these methods are to apply.
Like in other areas there are three critical success factors in the area of pharmaceutical development:
- clear and most precise target setting (e.g. from ICH Q8 QTPP)
- well structured organisation and business processes e.g. described and documented in a "development handbook" for ease of calculation and standardisation of issues and procedures
- relevant competence, expertise and know-how (with qualified personnel, whose qualification is continuously kept up to date by respective training)
PharmDev will be happy to assist you in managing all these three success factors.