Process ‘signature’

• Stages of the product manufacturing process can be characterized and then described based on the use of a variety of diverse measurement techniques

• This multi-dimensional profile can then be used to produce a process ‘signature’ which, in turn, offers a means of ensuring process reproducibility and robustness

• The process ‘signature’ may also be viewed as an end-point to work towards during scale-up or after equipment changes or site changes, for example

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