TRIPASS XR تري باس

 

Table 3.7: 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: It consists of changes of manufacturing site between facilities in adjacent

city blocks/site changes within a contiguous campus, or 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 3.8)

Table 3.8: Test documentation required as per SUPAC guidelines level 2

Sr. no. Type of test documentation Content

1. Chemistry documentation Location of new site

Updated batch records

Not beyond application/compendial release requirements

Annual report (with one batch on long-term stability data)

2. Dissolution documentation Not beyond application/compendial release requirements

3. In vivo bioequivalence None

documentation

SUPAC Guidelines and Platform Technology 33

Filing Documentation

i. Changes being affected supplement

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

c. Level 3

Definition: It consists of changes in manufacturing site to a totally different campus

(one that is not on the same original contiguous site or where the facilities are not in

adjacent city blocks), or 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 3.9)

Table 3.9: Test documentation required as per SUPAC guidelines level 3