The points offered are correct. Why do you have 2 different colors for the same formulation/dosage strength?
You do need to clearly address this in the rationale and your characterization scientists need to weigh in with a scientific discussion as to the fact that the color difference has no impact. In my pat life, we found that 1 color additive did indeed impact shelf life of all things.
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Frances Akelewicz
Owner & Principal
Practical Solutions
Yardley PA
United States
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Original Message:
Sent: 10-29-2013 09:37
From: Claudia Jackson
Subject: Process Validation
You must have two different colors for a reason. Your justification must take into account the intent of the two different colors and why it does not affect identity, safety, efficacy, strength or purity.
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Claudia Jackson
Milwaukee WI
United States
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Original Message:
Sent: 10-28-2013 12:36
From: Rizza Bernales
Subject: Process Validation
Can any of you please help me with this?
Scenario:
Two drug products with the same formula. Only difference is color.
Question:
These products are subject to process validation, is it acceptable to produce one big batch and split it in two different products with separate process validation reports? Can a justification be written that the only difference is the color and that this difference does not represent any risk or impact?
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Rizza Bernales