Transcription of Basic Principles of GMP - WHO
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Basic Principles of GMP - WHO
Module 14 |Slide 1 of 33 2013 Basic Principles of GMPB asic Principles of GMPT ransfer OfTechnologyPart 1 Annex 7. TRS 961, 2011 Module 14 |Slide 2 of 33 2013 Transfer of TechnologyTransfer of Technology Introduction Organization and management Premises and equipment Quality control: analytical method transfer Production: Processing, packaging and cleaning Qualification and validation DocumentationModule 14 |Slide 3 of 33 2013 Transfer of TechnologyTransfer of Technology Guideline provides guidance in addition to GMP Product may be transferred during: Development Scale up Commercial baatches - Site transfer (various possibilities) TOT defined as a logical procedure that controlsthe transferof any process together with its documentation and professional expertisebetween development and manufacture or between manufacturing sites . 14 |Slide 4 of 33 2013 Transfer of TechnologyTransfer of Technology Transfer includes: Documentation and ability Knowledge and experience Systematic process Documented plan in a quality system Development, Production and QC SU and 14 |Slide 5 of 33 2013 Transfer of TechnologyTransfer of TechnologySuccessful transfer needs: Project plan covering quality aspects based on quality risk management SU and RU to have similar capabilities, facilities
Module 14 | Slide 1 of 33 2013 Basic Principles of GMP Transfer Of Technology Part 1 Annex 7. TRS 961, 2011
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