Sr. no. Type of test documentation Content
1. Chemistry documentation Location of new site
Application/compendial release requirements
A significant body of information available
One batch with three months accelerated stability data
reported in the supplement; one batch on long-term
stability data reported in an annual report.
A significant body of information not available
Up to three batches with three months accelerated
stability data reported in the supplement; one batch
on long-term stability data reported in an annual
2. Dissolution documentation Case B: Low permeability, high solubility drugs
3. In vivo bioequivalence None
i. Changes being affected supplement
ii. Annual report (with long-term stability data)
C. Changes in Batch Sizes (Scale-up/Scale-down)
This section includes change after approval in the size of batch from pilot/pivotal
scale bio batch material to smaller or larger production batches call for additional
information's admission in the application. The batch scale-down below 10,000 dosage
unit is not covered by this document. The validation of all scale-up changes should be
done properly and should be inspected by authorised agency personnel, where needed.
Definition: It includes change in batch size, up to and including a factor of 10 times
the size of the pilot/bio batch, where
1. The equipment used to produce the test batch is of the same operating and design
2. The batch is manufactured in compliance with CGMPs; and
3. The same standard operating procedures (SOPs) and controls, as well as the same
manufacturing and formulation procedures, are on the full-scale production batch
and are used on the test batch.
Test documentation (Table 3.10)
Table 3.10: Test documentation required as per SUPAC guidelines level 1
Sr. no. Type of test documentation Content
1. Chemistry documentation Application/compendial release requirements
Submission of updated batch records
2. Dissolution documentation None beyond application/compendia requirements
3. In vivo bioequivalence None
Annual report (with long-term stability data)
Definition: It includes change in batch size, beyond the factor of 10 times the size of
1. The equipment used to produce the test batch is of the same operating and design
2. The batch is manufactured in compliance with CGMPs; and
3. The same standard operating procedures (SOPs) and controls, as well as the same
manufacturing and formulation procedures, are on the full-scale production batch
and are used on the test batch.
Test documentation (Table 3.11)
Table 3.11: Test documentation required as per SUPAC guidelines level 2
Sr. no. Type of test documentation Content
1. Chemistry documentation Application/compendial release requirements
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