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

AuthorMindy J Allport-Settle
BindingPaperback
EAN9780982147658
FormatImport
ISBN0982147651
Height900 mm
Length600 mm
Width147 mm
Weight189 g
LanguageEnglish
Language TypePublished
MPNblack & white illustrations
Number Of Items1
Number Of Pages650
Package Quantity1
Part Numberblack & white illustrations
Product GroupBook
Publication Date2010-05-22
PublisherPharmalogika
StudioPharmalogika
Sales Rank438910

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