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Development and validation of process analytical methods for a continuous pharmaceutical manufacturing process of tablets based on wet granulation

Book - Dissertation

Continuous processing is well established in the chemical, cosmetics and food industry, whilst it is still in its infancy in the pharmaceutical industry. However, there exists the intention to shift pharmaceutical manufacturing from traditional batch production towards continuous production. Continuous pharmaceutical manufacturing has several advantages, but with its implementation one major question rises as well: U+201CHow to assure the quality of both the in-process materials and the end product?U+201D. Indeed, the quality of pharmaceutical products obtained via traditional batch-wise processes is generally assessed via sampling and time-consuming off-line analyses in analytical laboratories. These quality evaluation methods would annul the advantages of continuous processing. It is clear that real-time quality assessment and control is indispensable for continuous production by means of Process Analytical Technology (PAT) tools. In this dissertation, the strengths and weaknesses of several complementary PAT tools, implemented in a continuous wet granulation process, which is part of a fully continuous from powder-to-tablet production line, were evaluated. Furthermore, the influence of raw material variability upon processability, intermediates and end products was investigated. Process understanding is gained and the presented approach fits in the Quality by Design (QbD) framework as it is presented by the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH).
Pages: 322 p.
Publication year:2014