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APIs manufacturing, either those on customer basis (e.g. NCE for clinical phases) or those for generic market, requires to build up a well-defined process that is not only cost-effective, but also leading to a drug substance with the required quality any time a campaign is performed. This means to have a robust and reproducible process, achievable only after a solid development phase. This activity can be tackled using two approaches:

• Traditional
• Enhanced

In a traditional approach, set points and operating ranges for process parameters are defined. The drug substance control strategy is typically based on demonstration of process reproducibility and testing to meet established acceptance criteria.

In an enhanced approach, risk management and scientific knowledge are used mo ... ...