Strategy of Process verification to use another granulation area

Validation
1

Dear All,

Suppose, I have two Granulation Suit, Granulation-1 and Granulation-2.
and I have validated product X in Granulation-1 and I want to use the Granulation-2 to manufacture the product X.
So, Can I carry out only one Process Verification batch instead of Three process validation batches??

I have following points for Justification:

  1. The equipments available in both the Granulation Suit have same operating capacity.

  2. Type of Granulation equipments are same.

  3. Both equipments have same operating parameters (Operating range is similar)

  4. Both have same principle and operating procedure.

  5. Different amperage reading, But, Product shall be executed with same total granulation time.

  6. Both have same geometric design.(Equipment similarity report available)

  7. Same make but different model No.

  8. Critical process parameters same.

  9. No Scale-up or Scale down.

  10. Batch size of the product x is same.

Also, I will perform comparative study for the following stage of manufacturing:

  1. Blend-Physical and chemical data.

  2. Tablets- Comparative dissolution profiling for Tablets manufactured by both the granulation Suit.

  3. Ongoing Stability sample shall be taken from the verification batch, for monitoring till self life.

So, upto how extent is this proposal is acceptable and appropriate!!

Or is it really required to conduct three process validation batches in Granulation-2.

2

In the area machines are equivalent. In that case no need for any verification batch, maximum if u want to do, go for 1 validation batch and stability.

1 Like
3

Thanks Mr. Pradeep,

But as you see the ampearage reading is different PMA granulator 1 is giving as 16 AMP and Advanced PMA granulator 2 is giving 6AMP as endpoint which is CPP, that creates a question …Hence, could you again go through it.