The environmental impact of “single-use plastics” has become a hot topic of societal and political debate. Despite the many technological advantages and innovations that plastic has enabled, it is now under closer scrutiny, especially those massively used in consumer market (plastic bottles, cutlery, straws, packaging, etc.).
Process validation (PV) aims at reassuring a manufacturer of constant product quality. Moreover, it is a regulatory requirement to achieve licensure of a pharmaceutical product Failing to efficiently plan and execute activities here leads to increased time-to-market. Statistics play a pivotal role here, as is shown by the fact that in the 22 pages of the latest FDA guidance document on process...
The needs of patients must always be at the forefront of what we do.
