Technology transfer from R&D to production

This is the topic related to Product development and technology transfer. In this we will learn how the technology is transferred from R&D department to production department in Pharmaceutical company

1. TECHNOLOGY TRANSFER FROM R&D TO PRODUCTION Rutuja Dattatray Chougale, Research Scholar, M. Pharm Semester I, Tatyasaheb Kore College of Pharmacy, Warananagar. 1

2. Technology transfer is transferring of details of concerning formulation and analytical strategies from one area to another area that’s from R&D to Production department and succeeding drug product from the laboratory scale to the production scale. Technology transfer is the process by which a developer of technology makes its technology available to a commercial partner that will exploit the technology. In pharmaceutical industry, “Technology transfer” refers to the process of successful progress from drug discovery to product development, clinical trials and ultimately full-scale commercialization. 2 INTRODUCTION

3. To explain the processing information to transfer technology from R&D to production site by listing out information gathered during R&D. To explain the processing information to transfer technology of already existing drug product between various places. To illustrate specific procedures and points to be considered for the above two types of technology transfer to contribute smooth technology transfer. 3 Objectives of Technology Transfer

4. Due to lack of manufacturing capacity. Due to lack of resources to launch product commercially. Due to lack of marketing distribution and distribution capability Forming alliance with partners Exploitation in a different field of application List of institutes assisting technology transfer- Asia Pacific Centre for Transfer of Technology (APCTT) Technology Bureau for small enterprise (TBSE) National research and development co-operation. 4 Reasons for technology transfer

5. 5 Technology transfer from various sectors

6. 6 Technology transfer process flow chart

7. The technology transfer team consists of : Process Technologist QA Representative Production Representative Engineering representative QC Representative 7 Technology Transfer Team

8. Role Responsibilities 1. Process Technologists Central focus for transfer activities. Collates documentation from the donor site. Performs initial assessment of the transferred project for feasibility, compatibility with site capabilities and establishes resource needs. 2. QA Representative Reviews documentation to work out compliance with marketing authorization. Reviews analytical strategies with QC to work out capabilities, instrumentation training requirements. Initiates conversion of donor site documentation into local systems or format. Initiates or confirms regulatory needs, e.g., an amendment to manufacturing license; variations to marketing authorization if method change needed, etc. 3. Production Representative Reviews process instructions (with process technologist) to verify capacity and capability. Consider any safety implications e.g., solvents, toxicity, sanitizing material. Considers the training requirements of supervisors or operators. 8 Roles of Technology Transfer Team

9. Role Responsibility 4. Engineering Representative Reviews (with production representatives) instrumentation requirement. Initiates required engineering modifications, change or part purchase. Reviews preventative maintenance and calibration impact, e.g., use of a lot of aggressive ingredients; more temperature-sensitivity method, and modifies consequently. 5. QC Representative Reviews analytical requirement Availability with instruments Responsible for analytical technique transfer for drug substance and drug product. 9 Roles of Technology Transfer Team

10. 10 Steps involved in Technology Transfer

11. R&D provides technology transfer dossier (TTD) document to a product development laboratory that contains all data of formulation and drug product as given below : Master Formula Card (MFC) – It includes product name along with its strength, generic name, MFC number, page number, effective date, shelf life, and market. Master Packaging Card – It provides data regarding packaging sort, the material used for packaging, stability profile of packaging and shelf life of packaging. 11 Technology transfer from R&D to Production (Development Phase)

12. Master Formula – It describes formulation order and manufacturing instructions. Formulation order and Manufacturing instructions offer the plan of process order, surroundings conditions needed and manufacturing instructions for the development of dosage form. Specifications and Standard Test Procedures (STPs) – These help to know active ingredients and excipients profile, in-process parameters and specifications, product release specifications and finished product. 12 Technology transfer from R&D to Production (Development Phase)

13. It depends on : Communication : Open communication between all team members Effective and timely communication with regulators Sending and receiving unit Technology transfer is not a “one way street” The sending unit and receiving unit must be equally involved in the process to ensure success Team work at all time 13 Success of Technology Transfer

14. Production master formula Manufacturing and Dispensing instructions Analytical methods Cleaning instructions and previous cleaning validation Active specifications and source Primary packaging material specifications and source Packaging instructions Process deviations file, Analytical deviation file Specimen manufacturing batch record 14 Checklist for technology transfer

15. Technology transfer creates a bridge between the R&D and production as it helps in creating more efficient and safe medications. The technology transfer does not mean one-time actions taken by the transferring party toward the transferred party however, suggest that continuous information exchange between the parties to maintain the product manufacturing. Development, transfer, production and documentation are the phases of technology transfer. There are certain checklist materials which are followed during technology transfer. 15 Conclusion

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