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Canadian Good Manufacturing Practices: Pharmaceutical, Biotechnology, and Medical Device Regulations and Guidance Concise Reference
Contributor(s): Allport-Settle, Mindy J. (Author)

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 ISBN: 0982147643     ISBN-13: 9780982147641
Publisher: Pharmalogika
OUR PRICE: $47.49  

Binding Type: Paperback
Published: April 2010
Qty:
Additional Information
BISAC Categories:
- Law | Science & Technology
Physical Information: 1.64" H x 7.01" W x 10" L (3.10 lbs) 828 pages
 
Descriptions, Reviews, Etc.
Publisher 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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