Could you explain more what do you exactly mean by process quantification and what the process is and what are your process parameters of interest?

It's not quantification, I am asking about process qualification in process validation in pharmaceutical industry. 

Sorry about that confusion. I understand what you meant now.

Any information available regarding the drug manufacturing process through FDA should be helpful indeed.

Have a look at these links:

http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070336.pdf

http://www.fda.gov/ohrms/dockets/ac/02/slides/3841s1_07_lachman/sld001.htm

Hope it helps,

SM

Some of the criteria might be process consistency (by X-R, X-S quality chart), process capability (Cp, Cpk ), precision (Gage R&R analysis), less variability and less rework needed.

I have studied the process qualification & validation in context of manufacturing industry. I am not sure how much of this will apply to pharmaceutical industry. However, I believe you may be able to find some common grounds. Take a look.

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