Finished Pharmaceutical Product

Detailed information related to qualitative and quantitative characteristics of the

finished product should be provided by SU to RU. The information includes:

i. Qualitative and quantitative composition

ii. Physical information

iii. Physical characteristics

iv. Method of manufacturing

v. In-process controls

vi. Packaging details

vii. Safety and handling details.

Information on Process (Processing)

History of process and other information should be provided to RU by SU. This is to

enable RU to perform any further development or optimization of the process after

the transfer of technology. This section includes information on:

i. Clinical development

ii. Scale-up activities

iii. Full-scale development act

iv. The history of change and reasons for the change

v. Problem’s investigation and respective outcomes.

SU should provide RU with any information regarding health, safety and

environmental issues. This information is associated with:

i. Manufacturing process

ii. Manufacturing process’s implications like the need for growing, etc

The SU should provide RU information on current processing and testing. This

section includes information regarding:

i. The requirement of facility and equipment

ii. Starting material details

iii. Master safety data sheet

iv. Storage requirements for FP, API, and excipients

v. Manufacturing steps description including flowcharts, narrative maps, master

batch-records, etc

vi. Analytical method description identification and justification of control strategy

which include:

a. Critical performance aspects of specific dosage forms

b. Process control points

c. Product quality attributes

d. Standard process control charts

78 Industrial Pharmacy II

vii. Validation

viii. Product quality reviews and details

ix. Stability information

x. Working protocols

xi. Environmental rules and protocols to be followed

Responsibilities of RU: RU should identify if there are any differences in the

i. Facilities

ii. Systems

iii. Capabilities