Level 1

Definition: This section includes process changes including changes such as operating

speeds and mixing times within application and validation ranges.

Test documentation (Table 3.14)

Table 3.14: Test documentation required as per SUPAC guidelines level 1

Sr. no. Type of test documentation Content

1. Chemistry documentation Not beyond application/compendial release

requirements

2. Dissolution documentation None beyond application/compendial requirements

3. In vivo bioequivalence None

documentation

Filing Documentation

Annual report

b. Level 2

Definition: This section includes process changes including changes such as operating

speeds and mixing times outside application and validation ranges.

Test Documentation (Table 3.15)

Table 3.15: Test documentation required as per SUPAC guidelines level 2

Sr. no. Type of test documentation Content

1. Chemistry documentation Application/compendial release requirements

Stability studies with one batch on long-term stability

data

Updated batch records