International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference
$44.99
Description
- 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]
- Part XI: Questions and Answers for Q8/9/10 Quality Guidance Documents
- Part XII: Combined Glossary and Index for all Quality Guidance Documents
Details
Looking for a comprehensive guide to international quality guidelines for the pharmaceutical, biologics, and medical device industries? Look no further than the International Conference on Harmonisation (ICH) Quality Guidelines Concise Reference Book. This invaluable resource provides an overview and orientation to help you navigate the complex landscape of quality regulations.
With the ICH Quality Guidelines, you'll have access to all the necessary information to ensure the stability, analytical validation, and quality of your products. Part I covers stability guidelines, including Q1A(R2), Q1B, Q1C, Q1D, and Q1E, while Part II focuses on analytical validation with Q2(R1). For addressing impurities, Part III includes Q3A(R2), Q3B(R2), and Q3C(R4).
The book also covers important topics such as pharmacopoeias, quality of biotechnological products, specifications, good manufacturing practice, pharmaceutical development, quality risk management, and pharmaceutical quality systems - making it a comprehensive reference tool for anyone involved in the industry. Part XI provides in-depth answers to frequently asked questions regarding Q8, Q9, and Q10 quality guidance documents.
If you're ready to stay on top of the latest quality guidelines and ensure compliance in your organization, the ICH Quality Guidelines Concise Reference Book is a must-have. Get your copy today and take your product quality to the next level.
Ready to improve your understanding of international quality guidelines? Get your copy of the ICH Quality Guidelines Concise Reference Book now!
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