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Re: PH4RM4C3UT1C4LS post# 226591

Friday, 09/09/2016 12:50:40 PM

Friday, September 09, 2016 12:50:40 PM

Post# of 402526
As a CSO that designed the operations for the new drugs, I and my team have authored the technical detail SOPs step-wise for the various unit operations. Yes there were from time to time some inputs from "others" in the non-technical wordings. Much the same ways that IP lawyers input their comments into Patents in cases of possible future litigation strategies.

In the case of $ELTP ADE SOP to be put in place there would be assurances of step-wise follow thru especially to assure against (1) API and Finished Products adulteration sources, (2) Cross contaminations from common air ducts misdesigns, (3) Inadequate sampling and verification before proceeding with the "next step" in the SOPs etc.
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