Process Validation

GOOD VALIDATION PRACTICE (cGVP)
1

A) For filing US DMF type II (for API), how many batches process vakidation data needs to be essentially submitted?. Can it be less than three ?

B) Is it necessary that three batches process validata data, conventionally submitted in the DMF has to be for the same batch size apart from same process and same equipment?

c) Is it necessary that at the time of using API in the ANDA, successful process vakidation on three batches should have been completed?

2

[quote=Vijay Kshirsagar]A) For filing US DMF type II (for API), how many batches process vakidation data needs to be essentially submitted?. Can it be less than three ?

B) Is it necessary that three batches process validata data, conventionally submitted in the DMF has to be for the same batch size apart from same process and same equipment?

c) Is it necessary that at the time of using API in the ANDA, successful process vakidation on three batches should have been completed?[/quote]

a. It should be no less than three.
b. Of course.
c. Yes.

3

Hi,

somebody know what are the criterions for revalidate in process validation of Active Farmaceuticals Ingredients?

for example if i change of manufacture plant but in the same site, i require revalidate the process?

if i scale up the process to 20% i need revalidate the process?

thanks for your comments

4

Dear

The conditions requiring revalidation and documentation are listed as follows.
1.Change or replacement in a critical of modular (capital) equipment
2.Change in a facility and /or plant (usually location or sit)
3.Significant (order of magnitude) increase or decrease in batch size
4.Sequential batches that fail to meet product and process specifications

Regards,
Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC, Ethiopia

5

Thanks a lot Shahid

But i have a problem, in my factory the changes as increse or decrease of batch size and change of manufacture plant in the same site are documented only as equivalet report, i think that it is incorrec, but i don´t have a sustenance or guiline that mention this.
may you help me with this.

6

Actually There is always a risk of having to modify process parameters or specifications over the period of time. Concurrent validation is important in these cases, however, that the system and equipment to be used have been fully qualified/validation previously. Concurrent validation may be used under certain circumstances based on validation team’s judgment call. It can be done with agreed parameters instead of full parameters. The justification for conducting concurrent validation must be documented and documents must be approved by validation team. The final report must be reviewed and approved before the product is released for sale.

Regards,
Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC, Ethiopia