So, you need to implement an effective CAPA process from the beginning. Remember those common citations? “Lack of adequate documentation” and “lack of adequate procedures” – these both should be addressed as early as possible.
Here are a few tips for better CAPA implementation:
- Create your CAPA process early, following recommended guidelines.
- Keep data centralized (such as with a software system) for better control.
- Keep your process as lean as possible to keep it easy to follow.
- Implement risk management within the first stage of a CAPA process.
- Make sure you clearly distinguish symptoms from causes. You need a clear definition of the problem to ensure you’re really getting to the root of it.
The other thing we’d say here is, even if you do end up with or have currently a 483 citation, it may not be too late to take action before it turns into something more serious. Preferably you’re so prepared that you have no citations, but otherwise, get back to basics with a good CAPA process to take care of any violations as soon as possible. They should be a wake-up call.
