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International Conference on Harmonisation (ICH) Quality Guidelines

- Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference

af Mindy J Allport-Settle
International Conference on Harmonisation (ICH) Quality Guidelines af Mindy J Allport-Settle
Bag om International Conference on Harmonisation (ICH) Quality Guidelines

ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability [Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation [Q2(R1)] * Part III: Impurities [Q3A(R2), Q3B(R2), Q3C(R4)] * Part IV: Pharmacopoeias (List Overview) * Part V: Quality of Biotechnological Products [Q5A(R1), Q5B, Q5C, Q5D, Q5E] * Part VI: Specifications [Q6A, Q6B] * Part VII: Good Manufacturing Practice [Q7] * Part VIII: Pharmaceutical Development [Q8(R2)] * Part IX: Quality Risk Management [Q9] * Part X: Pharmaceutical Quality System [Q10] Reference Tools * Part XI: Questions and Answers for Q8/9/10 Quality Guidance Documents * Part XII: Combined Glossary and Index for all Quality Guidance Documents

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  • Sprog:
  • Engelsk
  • ISBN:
  • 9780982147658
  • Indbinding:
  • Paperback
  • Sideantal:
  • 650
  • Udgivet:
  • 22. maj 2010
  • Størrelse:
  • 152x229x33 mm.
  • Vægt:
  • 857 g.
  • 2-3 uger.
  • 14. december 2024
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Beskrivelse af International Conference on Harmonisation (ICH) Quality Guidelines

ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability [Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation [Q2(R1)] * Part III: Impurities [Q3A(R2), Q3B(R2), Q3C(R4)] * Part IV: Pharmacopoeias (List Overview) * Part V: Quality of Biotechnological Products [Q5A(R1), Q5B, Q5C, Q5D, Q5E] * Part VI: Specifications [Q6A, Q6B] * Part VII: Good Manufacturing Practice [Q7] * Part VIII: Pharmaceutical Development [Q8(R2)] * Part IX: Quality Risk Management [Q9] * Part X: Pharmaceutical Quality System [Q10] Reference Tools * Part XI: Questions and Answers for Q8/9/10 Quality Guidance Documents * Part XII: Combined Glossary and Index for all Quality Guidance Documents

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