DOCUMENTATION IN TECHNOLOGY TRANSFER.pptx

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 1 ST 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. 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 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.

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

5. 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.

6. 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.

7. 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.

8. 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).

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

10. 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)

11. 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

12. 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

13. 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

14. 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.

15. (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.

16. The development report contains 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.

17. 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.

18. (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.

19. 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.

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