Control Strategy

An important step in developing a new drug is identifying critical quality characteristics, the aspects of the product that affect its safety and efficacy. Then our experts check how the production process affects those quality aspects. One of the questions they ask is which equipment and which settings are critical. Based on that analysis, they set up an appropriate control strategy, consisting of normal operating conditions during production, in-process controls, product specifications and associated analytical methods. The control strategy is then a key driver for process validation.