Things will go wrong from time to time. In the world of pharmaceuticals, we need to ensure that we have robust processes and procedure in place to deal with such situations. When an unplanned event arises it must be handled accordingly.
FDA’s Quality System Guide, recent Warning Letters and EU-GMP Chapter 1 clearly emphasise the increasing relevance of a proper deviation management and
CAPAs. ICH Q9 on Quality Risk Management and ICH Q10 on Pharmaceutical Quality Systems empower us to handle issues that arise in our daily work on the basis of risk analysis.
In any case a sound failure investigation is the key. Here it is also important to know how to deal with human error based and non-human error based non-conformances. Effective root cause analysis is the key to identifying appropriate CAPAs.
Independent from that, it needs to be pointed out that CAPA is an excellent Quality Management tool to continuously improve processes and avoid future failures. All personnel involved in the management of deviations and in CAPAs should aim to identify opportunities for further improvement