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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.
In terms of processes... 1). Evaluation: is determining whether the process in its entirety can yield an output that meets the desired requirements. 2). Validation: ... Voir Plus
Evaluation is a process to determine if the product or could be an individualon is meeting/not meeting or within the goal/ target or specification of the project or study ... Voir Plus
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
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