Deviation Cycle

GOOD VALIDATION PRACTICE (cGVP)
1

Dear All,

What is the Deviation Cycle, how many days a Deviation can be open. Can any one explain.

Thanks in advance…

R.Dasarath

2

I assume you are talking about deviations raised under a GMP system?

Your company should have a proceduralised deviation system which is maintained and monitored by QA (requirement of GMP). The deviation system should state how long different types deviations should be open.

Deviation systems should catagorise the “severity” or “importance” of the deviation on its effect on product quality/safety. So, for instance, you could have 3 catogories:

  • Cat 1 deviations which [b]directly[/b] affects product quality (e.g. either by contamination or incorrect processing.)
  • Cat 2 deviations which [b]indirectly[/b] affects product quality
  • Cat 3 deviations which have [b]no[/b] affect on product quality, but GMP is not met (e.g. paperwork is not completed correctly or a step in the SOP was not correctly followed)

Each of these categories differs in impact on product quality/safety so, obviously, will need to be dealt with more or less importance. Therefore, a cat 1 deviation will need to be raised, resolved and closed as quickly as possible, whereas a cat 3 deviation is not as important and, more often than not, involves retraining of staff or amending SOPS so will take longer to resolve. Once a deviation is raised, it should be categorised by QA as soon as practicably possible and entered into their tracking system.

It is difficult to give an exact time that deviations are allowed to be open, but typically this might be a week for “cat 1” from raising the deviation to final QA signoff, 4 weeks for “cat 2” and 3 months for “cat 3”. OBVIOUSLY the quicker the devation is resolved and closed, the better!

I hope that this answers your question. It is very brief, but deviation manangement is a big subject!

I would suggest that you speak to your company’s QA department for guidance. If they don’t have a formalised deviation system - they must set one up ASAP!!

3

Aside from what David mentions, I think it is also important to keep in mind that a deviation that affects the quality of the product must be closed before the production of a new batch.

When analyzing a deviation you must define if you can wait until the next batch is produced or if actions have to be implemented befor the production of a new batch, this will also set the time you will define to close the deviation.