i. Minimum and maximum capacity
ii. The material of construction
iii. Critical operating parameters
iv. Critical equipment components
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
ii. The impact of manufacturing new products on products currently manufactured
with the same equipment should be determined.
iii. Any modification of existing equipment that needs to be adapted to become
capable of reproducing the process being transferred should be documented in
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
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
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
6. Starting material SOPs, stability studies All information related to API
7. Equipment selection Side-by-side comparison Inventory list of all equipment
and transfer with RU equipment and systems, including makes, models,
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