Process validation

Dear All,

Can any one clear my query as mentioned below,

  1. I have validated a product with a batch size of 100 kgs at Granulation
    stage to Packing stage. I have compared the process validation data
    with Exhibit batch (Bio batch).
  2. Currnetly i have changed my batch size to 400kgs.

My query is, whether the current vaidated product is to be compared with
previously validated 100kg product or with my Exhibit batch(Bio batch).

Thanks in advance for your interest.


Dear Ravi,

In this case you have to match the Scale up batch with Exhibit batch.
Since during ANDA filling we provide the DR data of exhibit batch only, and there after validationcarried out,
and similarity of Drug release pattern is proven by doing DR profile and comparison (f1/f2) study.
so whenever any changes made (i.e. alternate granulation area, scale up, alternate compression machine, alternate coating machine, etc. should shawn comarability w.r.t. exhibit batch.

Dear Ravi

I totally agree with Nimeshborade.You have to validate the batch of new batch size but the comparision criteria should be same as that used for the first batch size, then and then only you can say that the product is validated.