Technology transfer from R&D to production

Involves Technology transfer from R&D to production department during product development.

1. Technology Transfer from R&D to Production Prepared by- Mr. deepak v. shanbhag First year m.pharm Semester 1 2018-19 Department of pharmaceutical quality assurance Bharati vidyapeeth college of pharmacy, kolhapur 1

2. Contents Introduction to Technology Transfer. Technology Transfer Team. Stages involved in technology transfer. Technology transfer from R&D to Production. Conclusion. References 2

3. Introduction to Technology Transfer Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites” . 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 processes of successful progress from drug discovery to product development, clinical trials and ultimately full-scale commercialization. 3

4. Introduction to technology transfer Technology transfer from various sectors. 4

5. Introduction to technology transfer Technology transfer process flow chart 5

6. Introduction to technology transfer Reasons for Technology transfer. 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 alliances with partners. Forming alliances with partners with manufacturing capability. Forming alliances with partners with marketing and distribution capability. Exploitation in a different field of application.  List of institutes assisting in technology transfer- -Asia Pacific Center for Transfer of Technology (APCTT) -Technology Bureau for small enterprise(TBSE) -National research and development co-operation. 6

7. Technology Transfer Team (TT team) The technology transfer team consist of following- R&D process technologist. QA representative. Production representative. Engineering representative. QC representative. 7

8. Technology Transfer Team (TT team) Roles and Responsibilities Roles Responsibilities Process Technologist Central focus for transfer activities. Collates documents and internal assessment taken by him for feasibility, compatibility,etc . QA Representative Reviews documentation to determine compliance with marketing authorization (MA). Reviews analytical methods with QC to determine capability, equipment training requirements. Initiates conversion of donor site documentation into local systems or format. Initiates or confirms regulatory requirements. Production representative Reviews process instructions (with process technologist) to confirm capacity and capability. Considers any safety implications, e.g., solvents; toxic; sanitizing materials. Considers impact on local standard operating procedures (SOPs). Considers training requirements of supervisors or operators.  8

9. Technology Transfer Team (TT team) Roles and Responsibilities Roles Responsibilities Engineering Representative Reviews (with production representative) equipment requirement. Initiates required engineering modifications, change or part purchase. Reviews preventative maintenance and calibration impact. QC Representative Reviews analytical requirement. Availability with instruments. Responsible for analytical method transfer for drug substance and drug product. 9

10. Stages involved in Technology transfer process 10

11. Technology transfer from R&D to Production R&D provides technology transfer dossier (TTD) document to product development laboratory, which contains all information of formulation and drug product as follows-   - Master Formula Card (MFC)– Includes product name along with its strength, generic name, MFC number, page number, effective date, shelf life and market. - Master Packing Card– Gives information about packaging type, material used for packaging, stability profile and shelf life of packaging. 11

12. Technology transfer from R&D to Production continued… - Master Formula– Describes formulation order and manufacturing instructions. (Process order and environment conditions) - Specifications and Standard Test Procedures (STP’S)– Helps to know active ingredients and excipients profile, in-process parameters, product release specifications and finished product details 12

13. Technology transfer from R&D to Production Roles and responsibilities Giving Site Provide Latest Source documentation. Latest Specifications (Internal or registered) Provide process(technology) transfer. Protocol/report (analytical report method) Receiving site Execute Protocol(analytical method) Qualified Facility and equipment or instrument. Setup system Setup training program. 13

14. Technology transfer from R&D to Production Success of technology transfer  It depends on Communication – Open communication between all team members – Direct communication between technical 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 14

15. Technology transfer from R&D to Production Checklist for technology transfer It consists of, 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 deviations file. Specimen manufacturing batch record. 15

16. Conclusion Technology transfer creates a bridge between the R&D and Production as it helps in creating more efficient and safe medications. This is systematic process with proper protocol which should be followed by both the ends while a QA personnel should verify and maintain the documentation included in these protocol. Development, transfer, production and documentation are the phases of technology transfer. There are certain checklist materials which are followed during technology transfer. 16

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