Rephine’s Alessandro Manni, Consultant and Auditor, explains
Different key aspects contribute to making a GMP audit successful. Amongst these is starting off on the right foot: be prepared for that.
Your mindset is very important. Never think “It’s just a GMP audit…an API…I’ve done tens of these worldwide!”. Each one is a whole other story.
What do I need for preparing a GMP audit?
Sometimes you are lucky. You are provided with the previous audit report. This is a very good starting point. Read it carefully with a focus on the observations which were noted. This gives you an idea on the weak points of the site you are going to audit. Being aware of this information will help you in verifying, including during the site tour, if the proposed CAPAs were effective or not.
1. Time is precious, and you have never enough
One of my favorite auditor mantras is “Time is precious, and you have never enough”, so don’t waste it. Go back to the previous audit report and figure out the strong points. For instance, one strong point of the site could be dedicated equipment for the product in scope. This means you can save time during document review: cleaning validation is never an easy topic. Knowing in anticipation the good points will help you enormously in developing an effective risk-based approach to the audit. You’ll put on high priority topics which were not reviewed or showed to be non- compliant during the previous audit.
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