Sr. no. Type of test documentation Content

1. Chemistry documentation Location of new site

Updated batch records

Application/compendial release requirements

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 B: Low permeability, high solubility drugs

3. In vivo bioequivalence None

documentation

Filing Documentation

i. Changes being affected supplement

ii. Annual report (with long-term stability data)

C. Changes in Batch Sizes (Scale-up/Scale-down)

This section includes change after approval in the size of batch from pilot/pivotal

scale bio batch material to smaller or larger production batches call for additional

information's admission in the application. The batch scale-down below 10,000 dosage

unit is not covered by this document. The validation of all scale-up changes should be

done properly and should be inspected by authorised agency personnel, where needed.

a. Level 1

Definition: It includes change in batch size, up to and including a factor of 10 times

the size of the pilot/bio batch, where

34 Industrial Pharmacy II

1. The equipment used to produce the test batch is of the same operating and design

principles;

2. The batch is manufactured in compliance with CGMPs; and

3. The same standard operating procedures (SOPs) and controls, as well as the same

manufacturing and formulation procedures, are on the full-scale production batch

and are used on the test batch.

Test documentation (Table 3.10)

Table 3.10: Test documentation required as per SUPAC guidelines level 1

Sr. no. Type of test documentation Content

1. Chemistry documentation Application/compendial release requirements

Notification of changes

Submission of updated batch records

Annual report

2. Dissolution documentation None beyond application/compendia requirements

3. In vivo bioequivalence None

documentation

Filing Documentation

Annual report (with long-term stability data)

b. Level 2

Definition: It includes change in batch size, beyond the factor of 10 times the size of

the pilot/bio batch, where

1. The equipment used to produce the test batch is of the same operating and design

principles;

2. The batch is manufactured in compliance with CGMPs; and

3. The same standard operating procedures (SOPs) and controls, as well as the same

manufacturing and formulation procedures, are on the full-scale production batch

and are used on the test batch.

Test documentation (Table 3.11)

Table 3.11: Test documentation required as per SUPAC guidelines level 2

Sr. no. Type of test documentation Content

1. Chemistry documentation Application/compendial release requirements

Notification of changes