Submission of updated batch records
Annual report (with one batch with three months
accelerated and one batch on long-term stability data)
2. Dissolution documentation Case B testing
3. In vivo bioequivalence None
i. Changes being affected supplement
ii. Annual report (with long-term stability data)
SUPAC Guidelines and Platform Technology 35
This section includes changes in both equipment as well as process.
Definition: This consists of (1) change from non-mechanical or non-automated
equipment to mechanical or automated equipment to move ingredients; and (2) Change
to alternative equipment of the same operating and design principles of the same
Test documentation (Table 3.12)
Table 3.12: Test documentation required as per SUPAC guidelines level 1
Sr. no. Type of test documentation Content
1. Chemistry documentation Application/compendial release requirements
Stability (one batch on long-term stability studies)
2. Dissolution documentation None beyond application/compendial requirements
3. In vivo bioequivalence None
Annual report (long-term stability data)
Definition: It consists of change to a different: (1) Design (2) Operating system
Test documentation (Table 3.13)
Table 3.13: Test documentation required as per SUPAC guidelines level 2
Sr. no. Type of test documentation Content
1. Chemistry documentation Application/compendial release requirements
Stability (one batch on long-term stability studies),
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 C: Dissolution profile.
3. In vivo bioequivalence None
i. Prior approval supplement with justification for change;
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