Audit readiness in Pharma industry and facing a regulatory audit

Audit is always additional headache for Pharmaceutical industry.  People from lower level to higher management are afraid for any regulatory audit. But facing of audit is not like a rocket science. As we are working for our organization same way auditors are working for their regulatory authority.

We are the knowledgeable fellow of our organization, because we are handling the process/ system routinely. Auditor who is not a part of our organization and even they know less and understand less about our organization. How can they able to find a single fault of our system? If it is so, then it is a big question on the understanding of our own system.

Some time in my experience I have observed that when auditor ask any SOP, we read it in front of auditor and struggle to get the information what the auditor ask. It seems that first time we are reading or we have seen that SOP. Try to explore the people those who are handing the procedure every day. Don’t try to justify more in front of auditor or don’t do more knowledge sharing in front of auditor. Just be with your written approved procedure only. The main principle of audit is tell whatever written in your approved procedure and show whatever evidence you have.