Other Beyond 0.2

Film coat Beyond 2

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

records, if

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

0.1 N HCl.

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.

32 Industrial Pharmacy II

Filing Documentation

i. Prior approval supplement (all information including accelerated stability data)

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

B. Site Changes

This section consists of changes in the location of the manufacturing site either of the

manufacturer or contract manufacturing facilities. This section does not include scaleup changes. The site should be in accordance with CGMP guidelines.

a. Level 1

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).

Test documentation (Table 3.7)