GMP Audit Planning for on-Time Auditing

First, begin with the yearly GMP Audit schedule. Involve as many of the auditees as practical. Take into account the strategic issues and once you are finished, stick to the plan (as best you can). Make sure all lines of communication stay open and the auditees are continually informed of the plan.

On the tactical side, once you have your GMP Audit plan and schedule developed for the actual GMP Audit, ensure it is communicated to all concerned. Make sure you have enough GMP Auditors and they are prepared well in advance, so you can maximize the time allocated to the GMP Audit.

Keeping to the GMP Audit schedule is tough, at times. GMP Auditors must do their best to maintain the schedule. When it is not possible, then the auditees need to be informed. If you are scheduled to be in QC Lab at 1:00 and don’t arrive until 3:00, the GMP Audit will probably not be as effective as you would desire.