DIONIGIO FRANCHI, Pharmaceutical Professional, Milano, ITALY (dionigio.franchi@gmail.com)
In the Pharmaceutical Industry GLPs/GMPs/GCPs provide guidance for documentation, materials, equipment, etc. through a matrix of principles and strategies to ensure the Safety, Strength, Purity and Quality of the Product.
In Academic and non-GLP/GMP R&D Organizations, non-GxP activities are governed by Good Science Practices (GSP) applyied to Experiments and Data, Methods and Processes, Technology Transfer, Publications, Thesis and Grants etc.
Quality by Design (QbD), is a new paradigm for the development of pharmaceutical products and it provides “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”. Quality is ‘designed into‘ the product and manufacturing process as opposed to ‘tested into‘.
The lecture will discuss how to establish and build a Quality Culture into non-GLP/GMP R&D and Academic Organizations by implementing procedures and strategies for the critical systems involved.
Practical incorporation of GLP/GMP Quality concepts and Quality by Design guidance into Academic and R&D Organizations will be presented.
This will bring into non-GLP/GMP R&D and Academic Organizations consistency and control, remove variables and minimizes errors, add confidence to interpretations and conclusions, strengthen the overall quality & reliability of the data, data integrity and good documentation practices, technology transfer process efficient and effective with the enhancement of the overall value.
REFERENCES
Guidance for Industry Q8(R2) Pharmaceutical development, 2009 (ICH Q8 (R2)
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf
Abstract Reference & Short Personal Biography of Presenting Author
Education and Professional Qualification
Doctor in Chemistry, University of Padova, Italy (1976); Post-Doc, University of Padova, Italy (1978); Research Associate, Dept of Biochemistry, Medical School, University of Maryland, USA (1978 -1979); Researcher University of Padova, Italy (1979 – 1980).
Academic and external involvement
Organized & Produced by: |
POB 4043, Ness Ziona 70400, Israel |