What Should Be The Content Of Process Validation Protocol?

1.	What Should Be The Content Of Process Validation Protocol?
Answer» GENERAL information Objective Background/Pre validation Activities, Summary of development and tech transfer (from R&AMP;D or another Site) activities to justify in-process testing and controls; any PREVIOUS validations. List of EQUIPMENT and their qualification status Facilities qualification Process flow charts Manufacturing PROCEDURE narrative List of critical processing parameters and critical excipients Sampling, tests and specifications Acceptance criteria

Answer»

GENERAL information
Objective
Background/Pre validation Activities, Summary of development and tech transfer (from R&AMP;D or another Site) activities to justify in-process testing and controls; any PREVIOUS validations.
List of EQUIPMENT and their qualification status
Facilities qualification
Process flow charts
Manufacturing PROCEDURE narrative
List of critical processing parameters and critical excipients
Sampling, tests and specifications
Acceptance criteria

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