Technology transfer strategies and documentation in pharmaceutical industry

1. Guided by: Ms. Kajal Pradhan
Assistant professor
(M.Pharm pharmaceutics)
Documentation of technology transfer in
Pharma Industries (According to WHO)
Presented by: Nidhi Joshi
Enroll no:202630290016
B.Pharm sem.7

2. What is it?
Technology transfer is the process of transferring
scientific findings and innovations to the
commercial sector for further development into
new products or services.
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GTU QUESTION:
Describe documentation requirement for transfer the technology from R&D to manufacture level.
Smt R.D.Gardi B.Pharmacy college Nyara,Rajkot

3. • Table of Contents
 Project Definition  Quality Agreement
 Facility Assessment  Skill Set Analysis and Training
 Analytical Method Transfer  Starting Material Evaluation
 Equipment Selection and Transfer  Process Transfer: Manufacturing
and Packaging
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4. Project Definition
1 By SU
Training protocols, assessment results
2 TRANSFER DOCUMENTS FOR TOT
Project implementation plan TOT protocol .
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5. Quality Agreement and Facility Assessment:
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Quality Agreement
Plans and layout of facility, buildings (construction, finish) Qualification
status (DQ, IQ, OQ) and reports by SU
Facility Assessment
(TD)Plans and layout of facility, buildings (construction, finish)
Qualification status (DQ, IQ, OQ) and reports

6. Health and Safety Assessment:
1
BY SU
Product-specific waste
management plans Contingency
plans
2
TRANSFER DOCUMENT
Conduct a risk assessment to assess
the potential harm to health and safety
related to the process.
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RISK ASSESSMENT
Create a safety plan to protect
employees and provide training
programs that meet the
requirements of the process.
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7. Skill Set Analysis and Training:
BY SU
SOPs and training
documentation
(product-specific
operations, analysis,
testing
TRANSFER DOCUMENT
Training protocols,
assessment results
Training Implementation
implement the training
program through various
delivery methods,, online
courses, and on-the-job
training.
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8. Starting Material Evaluation, Equipment Selection,
and Transfer:
1
By SU
Specifications and additional information on APIs,
excipients Inventory list of all equipment and
systems, including makes, models, qualification
status (IQ, OQ, PQ). Drawings, manuals, logs, SOPs
(e.g. set-up, operation, cleaning, maintenance,
calibration, storage)
2
Transfer document
Side-by-side comparison with RU equipment
(makes, models, qualification status) Gap
analysis. Qualification and validation protocol
and report
3
Equipment Transfer
Migrate the equipment, ensuring
that all related quality and safety
documents are properly
documented, and that personnel
receive appropriate training on the
new equipment.
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9. Analytical Method Transfer
Method Transfer Plan
Analytical method
specifications and
validation, including in-
process quality control
by SU
Performance
Qualification
(TD)Analytical methods
transfer protocol and report
Control Strategies
Control strategies should be put in
place to ensure ongoing
maintenance of the analytical
methods, including regular
verification and monitoring of the
methods to guarantee their
continued suitability for their
intended purpose.
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10. Process Transfer: Manufacturing and Packaging
Manufacturing
Reference batches (clinical, dossier, bio-batches)
Development report (manufacturing process
rationale),History of critical analytical data Rationale for
specifications, Change control documentation, Critical
manufacturing process Parameters Process validation
reports Drug master file. API validation status and
report(s) Product stability data Current master batch
manufacturing and packaging records List of all batches
produced Deviation reports, Investigations, complaints
BY SU
Packaging
History of process development at RU,
Experiences at RU should be recorded for future
reference Provisional batch mfg document (RU to
develop) Provisional batch packaging document
(RU to develop) Description of process at RU
(narrative, process map, flow chart) Process
validation protocol and report( TRANSFER
DOCUMENT)
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11. Cleaning
1 Cleaning Validation Procedures
Solubility information, therapeutic doses,
Category(toxicology), cleaning SOP, validation
reports chemical and micro agents used.
2 Transfer document
Product and site specific SOPs at RU cleaning
validation protocol and report.
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12. Application Forms
Application Forms
These forms are used to align
stakeholders and serve as
essential documentation to
track milestones achieved
against the technology
transfer targets.
Documentation Folders
Documented technology transfer
between different sites also
means that all parties included in
the transfer have the necessary
documents, signatures, and
corresponding validation before
being signed off with an agreed-
upon quality agreement..
Archiving Files
All technology transfer
documentation should be
archived appropriately to be
easily traced for regulatory
inquiries. The documentation
should detail team members,
interactions, and reports and
be maintained throughout the
life cycle of the product.
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