On demand for new process analytical technologies applied to injectable drug products.

Currently, in the pharmaceutical manufacturing process of injectable drug products, quality is still assessed under a quality-by-test system, wherein the product quality is evaluated at fixed manufacturing steps and in the end product. The introduction of the quality by design (QbD) approach, supported on process analytical technologies (PAT) is changing this paradigm. Efficiently understanding the process parameters and material attributes and how they affect the quality profile of the final product is increasingly a real need. In this context, all manufacturing steps should be ideally monitored as they are carried out, following the evolution of quality throughout the entire process. The PAT application to injectable drug products is still in its infancy since several constraints are raised mainly due to the solvent influence. This mini-review aims at identifying PAT potentially suitable for injectable analysis and foster their adoption by the pharmaceutical industries in their industrial processes, paving the way to enhanced quality and efficient processes.

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