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This scenario is where only one batch is produced in two to three years and building a separate facility as per GMP guidelines is not financially viable.
First of all we need to define validation for cleaning process. that is nothing but ask yourself Are we performing right clenaing process? Now we need to identify the obj ... Voir Plus
This really hard Question , for my self , I did not work in biotechnology field but if you need brainstorming , We need to agree at first that m.o not like chemicals , no ... Voir Plus
The most easiest and simple way to determine the progress of your fermentation are 1. smell the odour of fermentation 2. Spectrumentrical check the turbidity of broth as ... Voir Plus
Lactate Lactate Dehydrogenase LDH