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Solid Oral Dose Process Validation, Volume Two
- Lifecycle Approach Application
Engelsk
Bogcover for Solid Oral Dose Process Validation, Volume Two af Jordan Collins, Ajay Pazhayattil, Marzena Ingram, Emilija Fredro-Kumbaradzi, Naheed Sayeed-Desta, 9783030274832
Specifikationer
Sprog:
Engelsk
Sider:
108
ISBN-13:
9783030274832
Indbinding:
Hardback
ISBN-10:
3030274837
Kategori:
Udg. Dato:
20 sep 2019
Størrelse i cm:
23,5 x 15,5
Oplagsdato:
20 sep 2019

Solid Oral Dose Process Validation, Volume Two

- Lifecycle Approach Application
Engelsk
Hardback 2019
Format:

Bog beskrivelse

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.

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Specifikationer
Sprog:
Engelsk
Sider:
108
ISBN-13:
9783030274832
Indbinding:
Hardback
ISBN-10:
3030274837
Kategori:
Udg. Dato:
20 sep 2019
Størrelse i cm:
23,5 x 15,5
Oplagsdato:
20 sep 2019
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