TRIPASS XR تري باس

 

i. Minimum and maximum capacity

ii. The material of construction

iii. Critical operating parameters

iv. Critical equipment components

v. Critical quality attribute

vi. Range of intended use.

The gap analysis helps RU to:

i. Identify requirements for the adaptation of existing equipment.

ii. Identify requirements for the acquisition of new equipment.

iii. Identify requirements for change in the process.

iv. Identify requirements to reproduce the process being transferred.

During gap analysis following points should be kept monitored:

i. The facility and building-specific location of all equipment at the RU should be

considered at the time of drawing up process maps/flowcharts of the

manufacturing process to be transferred, including flows of personnel and

material.

ii. The impact of manufacturing new products on products currently manufactured

with the same equipment should be determined.

84 Industrial Pharmacy II

iii. Any modification of existing equipment that needs to be adapted to become

capable of reproducing the process being transferred should be documented in

the transfer project plan.

5.11 DOCUMENTATION

Documentation is the most essential part of the transfer process. Every key task has to

be documented. WHO guidelines mentioned a list of important documents that need

to be prepared. However, these documents can be amended depending upon the need

of time. The list of documents is given in Table 5.4.

5.12 QUALIFICATION AND VALIDATION

As per WHO guidelines the extent to qualification and/or validation to be performed

should be determined based on risk management principles and should be documented.

Table 5.4: Essential documents to be prepared during TOT process

Sr. no. Key task Name of document Information/documentation provided

by SU

1. Project definition Project implementation Project quality plan protocol, risk

plan. TOT protocol assessments, gap analysis

2. Quality agreement Side-by-side comparison Plans and layout

Facility assessment with RU facility and of facility, buildings

buildings; gap analysis

Qualification protocol

and report

3. Health and safety MSDS Product-specific waste management

assessment plans and contingency plans

4. Skill set analysis Training protocols, SOPs and training documentation

and training assessment results

5. Analytical method Analytical methods Analytical method specifications and

transfer transfer protocol validation

and report

6. Starting material SOPs, stability studies All information related to API

evaluation reports

7. Equipment selection Side-by-side comparison Inventory list of all equipment

and transfer with RU equipment and systems, including makes, models,