SlideShare a Scribd company logo
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
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.
2
GTU QUESTION:
Describe documentation requirement for transfer the technology from R&D to manufacture level.
Smt R.D.Gardi B.Pharmacy college Nyara,Rajkot
• 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
3
Project Definition
1 By SU
Training protocols, assessment results
2 TRANSFER DOCUMENTS FOR TOT
Project implementation plan TOT protocol .
4
Quality Agreement and Facility Assessment:
5
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
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.
3
RISK ASSESSMENT
Create a safety plan to protect
employees and provide training
programs that meet the
requirements of the process.
6
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.
7
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.
8
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.
9
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)
10
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.
11
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.
12
Technology transfer documentation and strategies

More Related Content

Similar to Technology transfer documentation and strategies

Qbd1
Qbd1Qbd1
Qbd1
Qbd1Qbd1
Technology development and transfer industrial pharmacy ll
Technology development and transfer industrial pharmacy llTechnology development and transfer industrial pharmacy ll
Technology development and transfer industrial pharmacy ll
Jafarali Masi
 
Technology transfer.pptx
Technology transfer.pptxTechnology transfer.pptx
Technology transfer.pptx
AshwiniBhoir2
 
Transfer technologypharmaceuticalmanufacturingtrs961annex7[1]
Transfer technologypharmaceuticalmanufacturingtrs961annex7[1]Transfer technologypharmaceuticalmanufacturingtrs961annex7[1]
Transfer technologypharmaceuticalmanufacturingtrs961annex7[1]
Flu Plant
 
DOCUMENTATION IN TECHNOLOGY TRANSFER.pptx
DOCUMENTATION IN TECHNOLOGY TRANSFER.pptxDOCUMENTATION IN TECHNOLOGY TRANSFER.pptx
DOCUMENTATION IN TECHNOLOGY TRANSFER.pptx
krutikanagpurkar1
 
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.
GvDurgamani
 
Phụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩm
Phụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩmPhụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩm
Phụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩm
Công ty Cổ phần Tư vấn Thiết kế GMP EU
 
Validation.pptx
Validation.pptxValidation.pptx
Validation.pptx
RakeshRaki79
 
TRS 937, 2006 ( validation HVAC).pdf
TRS 937, 2006 ( validation HVAC).pdfTRS 937, 2006 ( validation HVAC).pdf
TRS 937, 2006 ( validation HVAC).pdf
leminhle2
 
Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)
RushikeshPalkar1
 
TECHNOLOGY DEVELOPMENT AND TRANSFER PPT..pptx
TECHNOLOGY DEVELOPMENT AND TRANSFER PPT..pptxTECHNOLOGY DEVELOPMENT AND TRANSFER PPT..pptx
TECHNOLOGY DEVELOPMENT AND TRANSFER PPT..pptx
Abhishek Borkar15
 
Qualification and validation
Qualification and validationQualification and validation
Qualification and validation
Archana Mandava
 
Technology transfer
Technology transfer  Technology transfer
Technology transfer
Subhankar Das
 
Product development and technology transfer M pharm
Product development and technology transfer M pharmProduct development and technology transfer M pharm
Product development and technology transfer M pharm
PoojaWadgave
 
Process validation
Process validationProcess validation
Process validation
abhishek awasthi
 
Validation
ValidationValidation
Validation
Tarif Hussian
 
Seminar on validation by ranjeet singh
Seminar on validation by ranjeet singhSeminar on validation by ranjeet singh
Seminar on validation by ranjeet singh
Ranjeet Singh
 
Technology transfer
Technology transferTechnology transfer
Technology transfer
Jitendra manvar
 
Validation (1).pptx
Validation (1).pptxValidation (1).pptx
Validation (1).pptx
Yunesalsayadi
 

Similar to Technology transfer documentation and strategies (20)

Qbd1
Qbd1Qbd1
Qbd1
 
Qbd1
Qbd1Qbd1
Qbd1
 
Technology development and transfer industrial pharmacy ll
Technology development and transfer industrial pharmacy llTechnology development and transfer industrial pharmacy ll
Technology development and transfer industrial pharmacy ll
 
Technology transfer.pptx
Technology transfer.pptxTechnology transfer.pptx
Technology transfer.pptx
 
Transfer technologypharmaceuticalmanufacturingtrs961annex7[1]
Transfer technologypharmaceuticalmanufacturingtrs961annex7[1]Transfer technologypharmaceuticalmanufacturingtrs961annex7[1]
Transfer technologypharmaceuticalmanufacturingtrs961annex7[1]
 
DOCUMENTATION IN TECHNOLOGY TRANSFER.pptx
DOCUMENTATION IN TECHNOLOGY TRANSFER.pptxDOCUMENTATION IN TECHNOLOGY TRANSFER.pptx
DOCUMENTATION IN TECHNOLOGY TRANSFER.pptx
 
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.
WHO GUIDELINES FOR TECH.TRANSFER SIDHANTA SAHU.
 
Phụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩm
Phụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩmPhụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩm
Phụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩm
 
Validation.pptx
Validation.pptxValidation.pptx
Validation.pptx
 
TRS 937, 2006 ( validation HVAC).pdf
TRS 937, 2006 ( validation HVAC).pdfTRS 937, 2006 ( validation HVAC).pdf
TRS 937, 2006 ( validation HVAC).pdf
 
Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)
 
TECHNOLOGY DEVELOPMENT AND TRANSFER PPT..pptx
TECHNOLOGY DEVELOPMENT AND TRANSFER PPT..pptxTECHNOLOGY DEVELOPMENT AND TRANSFER PPT..pptx
TECHNOLOGY DEVELOPMENT AND TRANSFER PPT..pptx
 
Qualification and validation
Qualification and validationQualification and validation
Qualification and validation
 
Technology transfer
Technology transfer  Technology transfer
Technology transfer
 
Product development and technology transfer M pharm
Product development and technology transfer M pharmProduct development and technology transfer M pharm
Product development and technology transfer M pharm
 
Process validation
Process validationProcess validation
Process validation
 
Validation
ValidationValidation
Validation
 
Seminar on validation by ranjeet singh
Seminar on validation by ranjeet singhSeminar on validation by ranjeet singh
Seminar on validation by ranjeet singh
 
Technology transfer
Technology transferTechnology transfer
Technology transfer
 
Validation (1).pptx
Validation (1).pptxValidation (1).pptx
Validation (1).pptx
 

Recently uploaded

TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
rightmanforbloodline
 
Monopoly PCD Pharma Franchise in Tripura
Monopoly PCD Pharma Franchise in TripuraMonopoly PCD Pharma Franchise in Tripura
Monopoly PCD Pharma Franchise in Tripura
SKG Internationals
 
Mental Health and Physical Wellbeing.pdf
Mental Health and Physical Wellbeing.pdfMental Health and Physical Wellbeing.pdf
Mental Health and Physical Wellbeing.pdf
shindesupriya013
 
Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...
Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...
Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...
Lighthouse Retreat
 
Research, Monitoring and Evaluation, in Public Health
Research, Monitoring and Evaluation, in Public HealthResearch, Monitoring and Evaluation, in Public Health
Research, Monitoring and Evaluation, in Public Health
aghedogodday
 
Test bank clinical nursing skills a concept based approach 4e pearson educati...
Test bank clinical nursing skills a concept based approach 4e pearson educati...Test bank clinical nursing skills a concept based approach 4e pearson educati...
Test bank clinical nursing skills a concept based approach 4e pearson educati...
rightmanforbloodline
 
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
5sj7jxf7
 
Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.
Vishal kr Thakur
 
Faridkot ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Faridkot
Faridkot ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 FaridkotFaridkot ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Faridkot
Faridkot ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Faridkot
varun0kumar00
 
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
Media Logic
 
FACIAL NERVE
FACIAL NERVEFACIAL NERVE
FACIAL NERVE
aditigupta1117
 
Management of Post Operative Pain: to make doctors conscious about the benefi...
Management of Post Operative Pain: to make doctors conscious about the benefi...Management of Post Operative Pain: to make doctors conscious about the benefi...
Management of Post Operative Pain: to make doctors conscious about the benefi...
Nilima65
 
nursing management of patient with Empyema ppt
nursing management of patient with Empyema pptnursing management of patient with Empyema ppt
nursing management of patient with Empyema ppt
blessyjannu21
 
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
xkute
 
muscluskeletal assessment...........pptx
muscluskeletal assessment...........pptxmuscluskeletal assessment...........pptx
muscluskeletal assessment...........pptx
RushikeshHange1
 
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTNURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
blessyjannu21
 
Columbia毕业证书退学办理
Columbia毕业证书退学办理Columbia毕业证书退学办理
Columbia毕业证书退学办理
ozcot
 
The Ultimate Guide in Setting Up Market Research System in Health-Tech
The Ultimate Guide in Setting Up Market Research System in Health-TechThe Ultimate Guide in Setting Up Market Research System in Health-Tech
The Ultimate Guide in Setting Up Market Research System in Health-Tech
Gokul Rangarajan
 
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
The Lifesciences Magazine
 
The Importance of Black Women Understanding the Chemicals in Their Personal C...
The Importance of Black Women Understanding the Chemicals in Their Personal C...The Importance of Black Women Understanding the Chemicals in Their Personal C...
The Importance of Black Women Understanding the Chemicals in Their Personal C...
bkling
 

Recently uploaded (20)

TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
 
Monopoly PCD Pharma Franchise in Tripura
Monopoly PCD Pharma Franchise in TripuraMonopoly PCD Pharma Franchise in Tripura
Monopoly PCD Pharma Franchise in Tripura
 
Mental Health and Physical Wellbeing.pdf
Mental Health and Physical Wellbeing.pdfMental Health and Physical Wellbeing.pdf
Mental Health and Physical Wellbeing.pdf
 
Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...
Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...
Psychedelic Retreat Portugal - Escape to Lighthouse Retreats for an unforgett...
 
Research, Monitoring and Evaluation, in Public Health
Research, Monitoring and Evaluation, in Public HealthResearch, Monitoring and Evaluation, in Public Health
Research, Monitoring and Evaluation, in Public Health
 
Test bank clinical nursing skills a concept based approach 4e pearson educati...
Test bank clinical nursing skills a concept based approach 4e pearson educati...Test bank clinical nursing skills a concept based approach 4e pearson educati...
Test bank clinical nursing skills a concept based approach 4e pearson educati...
 
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
 
Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.
 
Faridkot ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Faridkot
Faridkot ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 FaridkotFaridkot ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Faridkot
Faridkot ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Faridkot
 
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
 
FACIAL NERVE
FACIAL NERVEFACIAL NERVE
FACIAL NERVE
 
Management of Post Operative Pain: to make doctors conscious about the benefi...
Management of Post Operative Pain: to make doctors conscious about the benefi...Management of Post Operative Pain: to make doctors conscious about the benefi...
Management of Post Operative Pain: to make doctors conscious about the benefi...
 
nursing management of patient with Empyema ppt
nursing management of patient with Empyema pptnursing management of patient with Empyema ppt
nursing management of patient with Empyema ppt
 
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
 
muscluskeletal assessment...........pptx
muscluskeletal assessment...........pptxmuscluskeletal assessment...........pptx
muscluskeletal assessment...........pptx
 
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTNURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
 
Columbia毕业证书退学办理
Columbia毕业证书退学办理Columbia毕业证书退学办理
Columbia毕业证书退学办理
 
The Ultimate Guide in Setting Up Market Research System in Health-Tech
The Ultimate Guide in Setting Up Market Research System in Health-TechThe Ultimate Guide in Setting Up Market Research System in Health-Tech
The Ultimate Guide in Setting Up Market Research System in Health-Tech
 
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
 
The Importance of Black Women Understanding the Chemicals in Their Personal C...
The Importance of Black Women Understanding the Chemicals in Their Personal C...The Importance of Black Women Understanding the Chemicals in Their Personal C...
The Importance of Black Women Understanding the Chemicals in Their Personal C...
 

Technology transfer documentation and strategies

  • 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. 2 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 3
  • 4. Project Definition 1 By SU Training protocols, assessment results 2 TRANSFER DOCUMENTS FOR TOT Project implementation plan TOT protocol . 4
  • 5. Quality Agreement and Facility Assessment: 5 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. 3 RISK ASSESSMENT Create a safety plan to protect employees and provide training programs that meet the requirements of the process. 6
  • 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. 7
  • 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. 8
  • 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. 9
  • 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) 10
  • 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. 11
  • 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. 12