WHO guidelines on transfer of technology

GUIDELINES RELATED TO TECHNOLOGY TRANSFER BY WHO

1. WHO guidelines on transfer of technology Dr. Kavita Bahmani Assistant Professor GJUS&T, Hisar , Haryana, India

2. Content Layout Introduction Organization and management Production: transfer (processing, packaging and cleaning) Quality control: analytical method transfer Premises and equipment Documentation Qualification and validation

3. 1. INTRODUCTION

4. 2. ORGANIZATION AND MANAGEMENT

5. Organization and management Transfer comprises an SU and an RU. In some circumstances there may be an additional unit which will be responsible for directing, managing and approving the transfer. There is a formal agreement between the parties, which specifies the responsibilities before, during and after transfer. There should be a project management plan which identifies and controls all the necessary activities identified at the start of the undertaking.

6. The transfer protocol IT CONSIST OF FOLLOWINGS

7. Points to be followed The SU should provide the necessary validation documentation for the process and its support functions The SU should provide criteria and information on hazards and critical steps associated with the product, process or method to be transferred, to serve as a basis for a quality risk management The SU or third party should assess the suitability and degree of preparedness of the RU before transfer, with regard to premises, equipment and support services (e.g. purchasing and inventory control mechanisms, quality control (QC) procedures, documentation, computer validation, site validation, equipment qualification, water for pharmaceutical production and waste management).

8. The SU and the RU should jointly verify that the following, satisfactorily completed, validation protocols are available or not

9. 3. Production : transfer (processing, packaging and cleaning

10. 3. Production: transfer (processing, packaging and cleaning)

11. BASIS OF TECHNOLOGY TRANSFER IN PRODUCTION

12. 4. QUALITY CONTROL

13. 4. Quality control : analytical method transfer

14. SU’s responsibilities for the transfer of analytical methods

15. RU’s responsibilities Appropriate training should be provided and all training activities and outcomes should be documented . Reference to compendial monographs where available, is expected.

16. 5. PREMISES & EQUIPMENT

17. Premises The SU should provide information to the RU on the layout, construction and finish of buildings and services The SU should provide information on relevant health, safety and environmental issues R isks of the manufacturing processes Health and safety requirements to minimize operator exposure Emergency planning considerations I dentification of waste streams and provisions for re-use, recycling and/or disposal

18. Equipment The SU should provide a list of equipment, makes and models involved in the manufacture, filling , packing and or control of the product , process or method to be transferred, together with existing qualification and validation documentation . The RU should review the information provided by the SU together with its own inventory list including the qualification status (IQ, OQ, PQ) of all equipment and systems, and perform a side-by-side comparison of equipment at the two sites in terms of their functionality, makes, models and qualification status . Any modification of existing equipment that needs to be adapted to become capable of reproducing the process being transferred should be documented in the transfer project plan drawings manuals maintenance logs calibration logs procedures maintenance , calibration and storage).

19. 6. DOCUMENTATION

20. Examples of documentation for transfer of technology (TOT)

21. 7. QUALIFICATION & VALIDATION

22. THANK YOU