a. Level 1

Definition: These are the changes that are unlikely to have any impact, i.e. detectable

in nature on the quality or performance of formulations.

Examples:

i. Change in colour or flavour of the formulation or change in the printing ink

ii. Changes in the excipients as per the following per cent ranges (based on

assumption that the drug substance in the formulation is 100% of as mentioned

on label/potency and the total additive change should not be more than 5%) are

given in Table 3.1.

Test documentation (Table 3.2)

Filing Documentation

Annual report (that includes long-term stability data and all other information)

b. Level 2

Definition: These are the changes that could have a significant impact on the quality

or performance of formulations.

Examples:

i. Change in the technical grade of an excipient

Table 3.1: Change in excipients (in %) as per SUPAC guidelines considered as level 1

Name of excipients Percentage excipient of total target dosage form weight (± n %)

Filler 5

Disintegrant

Starch 3

Other 1

Binder 0.5

Lubricant

Calcium or magnesium sterate 0.25

Other 1

Glidant

Talc 1

Other 0.1

Film coat 1

Table 3.2: Test documentation required as per SUPAC guidelines level 1

Sr. no. Type of test documentation Content

1. Chemistry documentation Application/compendial release

requirements and stability testing

2. Dissolution documentation None beyond application/compendial

requirements