Canadian Good Manufacturing Practices: Pharmaceutical, Biotechnology, and Medical Device Regulations and Guidance Concise Reference
ISBN-13:
9780982147641
ISBN-10:
0982147643
Author:
Mindy J. Allport-Settle
Publication date:
2010
Publisher:
PharmaLogika
Format:
Paperback
828 pages
Category:
Science & Technology
,
Legal Theory & Systems
FREE US shipping
Book details
ISBN-13:
9780982147641
ISBN-10:
0982147643
Author:
Mindy J. Allport-Settle
Publication date:
2010
Publisher:
PharmaLogika
Format:
Paperback
828 pages
Category:
Science & Technology
,
Legal Theory & Systems
Summary
Canadian Good Manufacturing Practices: Pharmaceutical, Biotechnology, and Medical Device Regulations and Guidance Concise Reference (ISBN-13: 9780982147641 and ISBN-10: 0982147643), written by authors
Mindy J. Allport-Settle, was published by PharmaLogika in 2010.
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Description
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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