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Extension - what is the key to do it in a compliant way?

I'm sure you need to work with deadlines. 30 days' lead-time for deviation or complaint investigation, also hard deadlines for CAPAs and Change controls. And I'm also sure you take them seriously.

Okay. But there's compliance, and there's real life. In other words:

'Many are the plans in a person's heart, but it is the Lord's purpose that prevails.' * :)


So what types of records are we talking about primarily? Let's focus on deviations/investigations, CAPAs and change controls. Their scheduling is key, but due to different reasons.

What can make us have to extend the deadline for closure? I have to say: almost anything :/

Lack of (any kind of) resources, delayed reaction from vendor, finding out the issue/task is much more complex than previously anticipated...anything.

And that's alright, it can be indeed your part of life, can happen to anyone, any time.

Reasoning - risk-based approach

You have your record to expire, so first you need to have a Plan B. A second deadline. This time, a firm one, if possible. But what can you register in your record next to this new deadline?

The most important topic to touch is through the risk-based approach. What is still pending until you close the record? Does it have any impact on validated processes? If yes, what makes you sure that without concluding the record you are still able to conduct that process (continue with the manufacturing when a related deviation is still without root cause, as an example). Go ahead and justify the new deadlines with detailing how the process is still valid.

In case of CAPAs (and possible change controls), you may also have a scenario, when you are to implement a corrective and a preventive action for the same phenomenon. In this case, you can use the implemented corrective action as an excuse for the delay of the preventive action. In other words, you are able to correct the potential failure, you are just not able to prevent it.

Temporary BCP until record conclusion

If you see that you are really far from concluding the record (my most unfamous example can be a CAPA, where heavy money is needed to implement, but you find out later you don't have the money), what can you do - apart from extending the record?

Establish a temporary sort of Business Continuity Plan: until you implement your CAPA, you develop cheaper and quicker-to-implement solution to gain the same control on your process. You can handle that solution in another record, or in the original, whatever is more comfortable for you - you only need to prove you have the full control on your validated processes.

What not to use as argument?

There is a chance (like I mentioned above) that you cannot conclude a record due to resource issues. The responsible people have a ton of other things to do, the machine to buy became 2-times more expensive, etc.

But never use these arguments in a GMP record! Don't forget what ICH Q10 says (Section 2.4):

(a) Management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the pharmaceutical quality system and continually improve its effectiveness.

(b) Management should ensure that resources are appropriately applied to a Pharmaceutical Quality System 6 specific product, process or site.

So - even if this is the real reason for the delay - restrain yourself from pointing it out.

It's not lying, it's diplomacy :)


* Proverbs 19,21

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