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Solid Oral Dose Process Validation, Volume Two
- Lifecycle Approach Application
Engelsk Hardback
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Solid Oral Dose Process Validation, Volume Two
- Lifecycle Approach Application
Engelsk Hardback

764 kr
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Om denne bog

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.

Product detaljer
Sprog:
Engelsk
Sider:
108
ISBN-13:
9783030274832
Indbinding:
Hardback
Udgave:
ISBN-10:
3030274837
Kategori:
Udg. Dato:
20 sep 2019
Længde:
0mm
Bredde:
155mm
Højde:
235mm
Forlag:
Springer Nature Switzerland AG
Oplagsdato:
20 sep 2019
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