Documentation in technology transfer covers technology transfer plan, technology transfer report,process validation protocol and report, etc.

1. DOCUMENTATION IN
TECHNOLOGY
TRANSFER
SUBMITTED BY:- MS. KRUTIKA S. NAGPURKAR
M.PHARM 1ST YEAR (Q.A)
SUBMITTED TO:- DR, RASHMI TRIVEDI MA’AM SMT. KISHORITAI BHOYAR COLLEGE OF
PHARMACY , KAMPTEE, NAGPUR-441002.

2. • Confidentiality Agreement
• Licensing
• Research And Development Report
• Technology Transfer Plan
• Technology Transfer Report
• Process Validation Protocol & Report
• Qualification And Validation Protocol & Report (For Equipment)
• Qualification Protocol And Report (For Facility)
• Cleaning Validation Protocol And Report
• Analytical Methods Transfer Protocol & Report
CONTENT:-

3. CONFIDENTIALITYAGREEMENT:-
• A confidentiality agreement also known as Non Disclosure Agreement (NDA)
which is simply a contract between two or more parties where subject of
agreement is promise that information conveyed will be maintained in
secrecy.
• Mutual agreement:-
where both parties obligated to maintain secrecy.
• Unilateral agreement:-
where only receiving party become obligated to maintain secrecy.
• This agreement are useful when both parties being conveying confedential
information, such as for inventory groups.

5. LICENSING:-
Licenses allow patent owners to share invention or other IP rights in
controlled manner and to receive revenue or other benefits.

6. RESEARCH AND DEVELOPMENT REPORT:-
Development report is a file of technical development and the research and
development and the development department is in-charge of its documentation.
It contains:-
• Raw materials, components and synthetic route.
• Rational and charge histories of important process and control parameters,
stability data.
• Specifications and test methods of drug substances, intermediates, drug
products, raw materials, and components, validity of specification range of
important tests, rational for selection of test methods, reagents and columns
and traceability of raw data of those information.

7. TECHNOLOGY TRANSFER PLAN:-
• Describe items and contents of technology to be transferred.
• Describe detailed procedures of individual transfer and transfer schedule.
• Establish judgement criteria for the completion of the transfer.
• The transferring party should prepare the plan before the implementation of
the transfer, and reach an agreement on its contents with the transferred
party.

8. TECHNOLOGY TRANSFER REPORT:-
• Report the data after technology transfer according to the technology plan.
• Evaluation the data and the predetermined judgment criteria.
• Regulatory inspectors and sometimes assessors will ask for evidence of
successful transfer.
• The report should also serve a similar function to the original development
pharmaceutics report in that it provides a “ready reckoner” of key aspects of
the product and a reference point in the future if problems are encountered.

9. Process validation protocol and
report:-
• 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).

10. • Product stability data
• Current master batch
• Manufacturing & packaging
• Records
• List of all batches produced
• Deviation reports
• Investigation, complaints
• Recalls
• Annual product review

11. QUALIFICATION AND VALIDATION PROTOCOL
AND REPORT(FOR EQUIPMENT)
• 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)

12. QUALIFICATION PROTOCOLAND REPORT(FOR
FACILITY)
• Plans and layout of facility,
• buildings (construction, finish)
• Utility service
• Fire risk
• Heath and safety requirement
• Qualification status (DQ(Design Qualification), IQ(Installation
Qualification), OQ(Operational Qualification) and reports

13. CLEANING VALIDATION PROTOCOLAND REPORT
• Cleaning validation, including: Solubility information;
therapeutic doses; toxicity of API
• existing cleaning SOPs
• validation reports - chemical and microbial cleaning agents
used
• recovery study

14. ANALYTICAL METHODS TRANSFER PROTOCOLAND
REPORT
• Analytical method specifications and validation, including in-process
quality control
• Acceptance criteria
• Interpretation result
• Reference standard
• Deviation during analysis
• Training should be provided to analysts and should be documented in
training protocol

15. TECHNOLOGY TRANSFER PROCESS
Generally interpreted as document indicating contents of technology transfer
for transferring and transferred parties. Each step from R&D to production
should be documented, task assignments and responsibilities should be clarified
and acceptance criteria for completion of technology transfer concerning
individual technology to be transferred. It is duty of Quality Assurance
department to check and approve the documentation for all processes of
technology transfer.

16. (a) Development Report-
The R&D report is a file of technical development, and R&D department is in-
charge of its documentation. This report is an important file to indicate rationale
for the quality design of drug substances and its specifications and test methods.
The development report is not prerequisite for the application for approval; it
can be used at the pre approval an inspection as valid document for quality
design of new drug.

17. The development report contains
(1)Data of pharmaceutical development of new drug substances and
drug products at stages from early development phase to final
application of approval.
(2) Information of raw materials and components.
(3) Design of manufacturing methods.
(4) Change in histories of important processes and control parameters.
(5) Specifications and test methods of drug substances.
(6) Validity of specification range of important tests such as contents
impurities and dissolution,
(7) Verifications of results.

18. b) Technology Transfer Plan
The technology transfer plan is to describe items and contents of technology
to be transferred and detailed procedures of individual transfer and transfer
schedule, establish judgment criteria for the completion of the transfer. The
transferring party should prepare the plan before the implementation of the
transfer and reach an agreement on its contents with the transferred party.

19. (c) Report-
Completion of technology transfer is to be made once data are taken
accordingly to the technology plan and are evaluated to confirm that the
predetermined judgment criteria are met. Both transferring and transferred
parties should document the technology transfer report.

20. E) Exhibit
After taking scale up batches of the product, manufacturing of exhibit batches
takes place. In case of exhibit, batch sizes are increased along with equipments
and their processes. This is done for filling purpose in regulatory agencies.

21. REFERENCE
http://www.who.intWHO
guidelines on transfer of technology in pharmaceutical manufacturing