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Canadian Good Manufacturing Practices: Pharmaceutical, Biotechnology, and Medical Device Regulations and Guidance Concise Reference

Autor Mindy J. Allport-Settle
en Limba Engleză Paperback – 31 mar 2010
Part I: Food and Drugs Act - Part A: Administration - Part C: Drugs Division 1 - Division 1A: Establishment Licences - Division 2: Good Manufacturing Practices Part II: Guidance Documents Part III: Annexes to the Current Edition of the Good Manufacturing Practices (GMP) Guidelines Part IV: Questions and Answers Part V: International Conference on Harmonisation (ICH) Guidance Documents - ICH Q1A(R2): Stability Testing of New Drug Substances and Products - ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products - ICH Q1C: Stability Testing for New Dosage Forms - ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology - ICH Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - ICH Q9: Quality Risk Management, Part VI: Compliance Policies Part VII: Forms Part VIII: Extensive Index
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Specificații

ISBN-13: 9780982147641
ISBN-10: 0982147643
Pagini: 828
Dimensiuni: 178 x 254 x 42 mm
Greutate: 1.41 kg
Editura: Pharmalogika