Failed Periodic Dose Audit or Bioburden drifting to Alarm level

Experiencing problems in Dose Audits or Bioburden?

Failing a Periodic Dose Audit might lead to delay in sales, product loss, quarantine or even recall.

It is important to know that only a limited number of failures are product related!

To prevent unwanted situations it is important to have a firm and stable Dose Audit and Bioburden Monitoring program.

In case of failing a Dose Audit I have much experience in Root Cause Analysis and managed to limit the possible risk.

Only staring on the problem is not my preferred approach, concentrating on the solution is... (Yes, CAPA driven)