Quality and Standardization for Globalization

  • Satoru Kimura
  • Yasuhide Nakamura
Part of the Trust book series (TRUST, volume 5)


The IMPACT did not explicitly define substandard medicines. This may be explained by the existence of the premise that “specification” is a self-evident thing. For manufacturing pharmaceutical products, there exist international concepts and norms integrated into the undertaking of Good Manufacturing Practice (GMP), which suggest the premise that if a medicine complies with the GMP, its quality will be controlled. When poor quality drugs are discussed, there is a tendency for concluding that such drugs are related to technical problems in terms of GMP, except when they involve criminal activity. The fact that modern medicines have specifications as industrial products has yielded many advantages. Specifically, drug regimens have become interchangeable beyond borders, and technology transfer has become practical, facilitating the spread of manufacturing and use of medicines across the world. Furthermore, specification and standardization of pharmaceutical products have resulted in stricter identification of disease concepts, and in more clear and precise decision-making for the indications of pharmaceuticals, which has formulated a positive cycle enabling further development of medicines. On the other hand, the spread of medicines across the world has also brought about the possibility of disseminating problems associated with product quality.


Compatibility GMP Quality Standardization Technology transfer 


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Copyright information

© Springer Nature Singapore Pte Ltd. 2020

Authors and Affiliations

  • Satoru Kimura
    • 1
  • Yasuhide Nakamura
    • 2
  1. 1.Department of Reference StandardsPharmaceutical and Device Regulatory Science Society of JapanOsakaJapan
  2. 2.School of Nursing and RehabilitationKonan Women’s UniversityKobeJapan

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