Test documentation (Table 3.6)
Table 3.6: Test documentation required as per SUPAC guidelines level 1
Sr. no. Type of test documentation Content
1. Chemistry documentation Application/compendial release requirements, batch
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 report.
2. Dissolution documentation Case A: High permeability, high solubility drugs
If Dissolution of 85% in 15 minutes in 900 ml of
Case B: Low permeability, high solubility
Case C: High permeability, low solubility drugs.
3. In vivo bioequivalence Full bioequivalence study. The bioequivalence study may
documentation be waived only if an acceptable in vivo and in vitro
correlation has been verified.
i. Prior approval supplement (all information including accelerated stability data)
ii. Annual report (that includes long-term stability data and all other information)
This section consists of changes in the location of the manufacturing site either of the
Definition: Level 1 changes consist of site changes within a single facility where the
standard operating procedures (SOPs), same equipment, same controls, personnel
common (employees already working on the campus who have suitable experience
with the manufacturing process) and same environmental conditions (e.g. temperature
and humidity) are used and no changes are made to the manufacturing batch records
(except for administrative information and the location of the facility).
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