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International Conference on Harmonisation (ICH) Quality Guidelines - Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference (Paperback)
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International Conference on Harmonisation (ICH) Quality Guidelines - Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference (Paperback)
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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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