Solid Oral Dose Process Validation, Volume Two Lifecycle Approach Application /

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 pr...

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Bibliographic Details
Main Authors: Pazhayattil, Ajay (Author, http://id.loc.gov/vocabulary/relators/aut), Sayeed-Desta, Naheed (http://id.loc.gov/vocabulary/relators/aut), Fredro-Kumbaradzi, Emilija (http://id.loc.gov/vocabulary/relators/aut), Ingram, Marzena (http://id.loc.gov/vocabulary/relators/aut), Collins, Jordan (http://id.loc.gov/vocabulary/relators/aut)
Corporate Author: SpringerLink (Online service)
Format: Electronic eBook
Language:English
Published: Cham : Springer International Publishing : Imprint: Springer, 2019.
Edition:1st ed. 2019.
Series:AAPS Introductions in the Pharmaceutical Sciences,
Subjects:
Online Access:Full Text via HEAL-Link
Description
Summary: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.
Physical Description:XII, 108 p. 83 illus., 60 illus. in color. online resource.
ISBN:9783030274849
ISSN:2522-834X
DOI:10.1007/978-3-030-27484-9