On Time GMP Audits

It is time once again for the GMP Audit. An API Audit? An Excipient Audit? A Primary Packaging Material Audit? Who knows?

Everything is ready. The auditees have been duly notified, and anxiously await your arrival. You have taken the time to prepare, studying the requirements and procedures.

You have looked at the previous audits and checklists. Your checklist is up to date, and you have your sampling plan and you know what evidence you will be looking for. The opening meeting is scheduled at 8:30, and you are there, the auditees are there, and everyone is ready to go. Sounds like a nearly perfect start to a nearly perfect audit, doesn’t it? But is it really? Are you auditing what you should be auditing, when it should be audited? Does it make a difference what you audit when? On-time auditing means you are auditing that function or activity at the exact time necessary to have the greatest impact on the Pharmaceutical QMS, the organization and the auditing program. It is required that audits be scheduled based on the activity’s relative importance, the status and the results of previous audits. But in scheduling audits, we must look way beyond that to develop a schedule that will yield the greatest benefit for the organization. In order to accomplish this, we must look at two things. The long-term, big picture and the short term. We must balance strategic needs, those having impact on the entire Pharmaceutical QMS, and tactical needs, those that impact an individual audit.