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Change control in validation

Hi everybody¡¡

I have a question, in active pharmaceutical ingredient industry if i have a process validated to scale of 500 kg and we need to change the batch size to 800 kg in the same equipment, is necessary the revalidation of process? or if i demostrate that the process is equivalent in it´s physicals and chemicals chacaracteristic is not necessary the revalidation?

Thanks for you help.

[quote=Oscar]Hi everybody¡¡

I have a question, in active pharmaceutical ingredient industry if i have a process validated to scale of 500 kg and we need to change the batch size to 800 kg in the same equipment, is necessary the revalidation of process? or if i demostrate that the process is equivalent in it´s physicals and chemicals chacaracteristic is not necessary the revalidation?

Thanks for you help.[/quote]

Dear Oscar
Typical changes that require revalidation include changes in a raw material or packaging material sources, changes in the process parameters, changes to equipment, including major repairs, change in batch size and changes to the premises. Because it can affect the process, so I suggest that process should go for revalidation. This suitation lie under te heading of revaldation after change.

Thanks

It is required to validate the things once again. When you have 500 kg batch size your mixing time, temperature conditions, the equipments for mixing, drying, crystalisation may be different and do not have how the impurity profile will work wih this chnage. The solvent level in samples will be different. The yeild is required to be validate with new batch size.
Summarized it is required to be validated

please please… revalidate

[quote=Oscar]Hi everybody¡¡

I have a question, in active pharmaceutical ingredient industry if i have a process validated to scale of 500 kg and we need to change the batch size to 800 kg in the same equipment, is necessary the revalidation of process? or if i demostrate that the process is equivalent in it´s physicals and chemicals chacaracteristic is not necessary the revalidation?

Thanks for you help.[/quote]
Hi Oscar
The change contro should be refered to validation team, to eatimate upto what level revalidation is required. A decision should come from Validation team whether full validation required or related parameters required to revalidate.

[quote=Oscar]Hi everybody¡¡

I have a question, in active pharmaceutical ingredient industry if i have a process validated to scale of 500 kg and we need to change the batch size to 800 kg in the same equipment, is necessary the revalidation of process? or if i demostrate that the process is equivalent in it´s physicals and chemicals chacaracteristic is not necessary the revalidation?

Thanks for you help.[/quote]

dear friend
definately it needs to go for revalidation even if you have same equivalent equipments.

Dear Oscar,
This is Jasbindersingh from Kamal Consultants.
Your batch size is changes from 500kg to 800kg. The change in the batch size is 60% of original / validated process. It is too high and calls for complete Validation.
Such a high change in the batch size will definitely affect the established parameters like:
 Increase in time required for each unit operation.
 Increase in cooling / heating attaining time.
 Increase in centrifugation / filtration time.
 Increase in drying time etc.
The above factors may effect on the impurity profile adversely. So, it is must to revalidate the process.

Regards,

Jasbindersingh
(kamal.consultants@hotmail.com)

Revalidate.

If you can’t successfully argue the need NOT to revalidate to your QA…your QA will not be able to successfully argue the need NOT to revalidate to ME.

That’s a simple stupid explanation, but when you look at everything that you do, or want to do, or did, think of the above statement and see if how your actions or inactions fit i n.

[quote=Oscar]Hi everybody¡¡

I have a question, in active pharmaceutical ingredient industry if i have a process validated to scale of 500 kg and we need to change the batch size to 800 kg in the same equipment, is necessary the revalidation of process? or if i demostrate that the process is equivalent in it´s physicals and chemicals chacaracteristic is not necessary the revalidation?

Thanks for you help.[/quote]

dear oscar

you have to validate your process again atleast for blend uniformity as load in your equipment is change.

thanks

amit