Documentation of Technology transfer

1. DOCUMENTATION OF
TECHNOLOGY TRANSFER
PRESENTED BY : PARTH RANA
M.PHARM : SEM 1
GUIDED BY: DR. AJAY I.
PATEL
M.PHARM; PH.D
ASSISTANT PROFESSOR
B.K. MODY GOVERNMENT PHARMACY COLLEGE, RAJKOT.

2. CONTENT
• Confidentiality agreement
• Licensing
• Research and Development Report
• Technology Transfer Plan
• Technology Transfer Report
• Process validation protocol and report
• Qualification and validation protocol and report(for Equipment)
• Qualification protocol and report(for Facility)
• Cleaning validation protocol
and report
• Analytical methods transfer protocol and report

3. CONFIDENTIALITY AGREEMENT
• 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 agreement is a promise that information conveyed will be maintained in
secrecy.
• Mutual agreement :
Where both parties are obligated to maintain secrecy.
• Unilateral agreement :
Where only receiving party become obligated to maintain secrecy.
• This agreements are useful when both parties being conveying confidential
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 benefites.

6. RESEARCH AND DEVELOPMENT REPORT:
• Development report is a file of technical development and the research and
development department is in-charge of its documentation. It contains:
• Raw materials , components and Synthetic route.
• Rational and change histories of important processes 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 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

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, biobatches)
• 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 and packaging
• records
• List of all batches produced
• Deviation reports
• Investigations, 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 PROTOCOL AND 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 PROTOCOL
AND 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 PROTOCOL AND
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. REFERENCE
http://www.who.int
WHO guidelines on transfer of technology in pharmaceutical
manufacturing.