Good Science Practices and Quality by Design applied to Academic and non-GLP/GMP R&D Organizations


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

Dr. Dionigio Franchi, Pharmaceutical Professional, Italy
  • Consultant to multinational and startup Healthcare and Research organizations in the field of GMP, Quality System and Quality by Design, dosage form development and filing, project reviews and definition of product development strategies.
  • Consultant at Fondazione Telethon, a major biomedical charity in Italy, whose mission is to advance biomedical research towards the cure of rare genetic diseases.
  • Consultant at Research Center Pharmaceutical Engineering GmbH; Graz, Austria.
  • Member of the Teaching Council and Faculty at the second level Master course for “Pharmaceutical Analytical Expert”, Department of Drug Sciences, University of Pavia, Italy
Professional Summary
  • Up to December 2010, Director Pharmaceutical Development Dept. R&D GlaxoSmithKline - Verona, Italy
  • With more than 25 years experience in GlaxoSmithKline Research and Development, working in highly productive and dynamic R&D Verona, Pre-Clinical worldwide organization with a solid track record of delivery projects from Candidate Selection to filing and launch.
  • Experience in a wide range of therapeutic areas including Anti-infectives, Cardiovalscular and CNS areas profiling and developing New Chemical Entities up to regulatory file submission.
  • Trainer and lecturer on various pharmaceutical related topics such: biopharmaceutics and drug delivery system; Pharmaceutical Quality System and Stability.
  • Registered Qualified Person (more than 10 year in the role for both Active Product Ingredient and Finished Product).

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

  • Faculty at Istituto Universitario di Studi Superiori (IUSS), Pavia Italy - Course on Creating Medicines to Medical Students (2010, 2011, 2012, 2013)
  • Faculty at University of Padova - Italy, School of Pharmacy - Course on Drug Development, University Degree: Informazione Scientifica del Farmaco (2004 – 2007)
  • Active member of the EUFEPS Committee for Industrial Relationships (CIRR) (2000 – 2010)

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