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

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Solid Oral Dose Process Validation, Volume Two/ by Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins.
其他題名:	Lifecycle Approach Application /
作者:	Pazhayattil, Ajay.
其他作者:	Sayeed-Desta, Naheed.
面頁冊數:	XII, 108 p. 83 illus., 60 illus. in color.online resource. :
Contained By:	Springer Nature eBook
標題:	Pharmacology. -
電子資源:	https://doi.org/10.1007/978-3-030-27484-9
ISBN:	9783030274849

Solid Oral Dose Process Validation, Volume Two = Lifecycle Approach Application /
Pazhayattil, Ajay.

Solid Oral Dose Process Validation, Volume TwoLifecycle Approach Application /[electronic resource] :by Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins. - 1st ed. 2019. - XII, 108 p. 83 illus., 60 illus. in color.online resource. - AAPS Introductions in the Pharmaceutical Sciences,2522-834X. - AAPS Introductions in the Pharmaceutical Sciences,.

Preface, Introduction, Chapter 1: Stage 1 Quality by Design Product Development QbD product development methodologies -- Chapter 2: Stage 1 Scale Up, Tech Transfer Process -- Considerations for process scale up and transfer -- Chapter 3: Stage 2 Batch determination, Sampling & Testing Plan -- PPQ batch determination method, scientifically supported sampling and testing plans -- Chapter 4: Stage 3A Continued Process Verification -- Stage 3A assessment methodology for newly launched products -- Chapter 5: Stage 3B Continued Process Verification -- Routine CPV monitoring plan for commercial products.

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.

ISBN: 9783030274849

Standard No.: 10.1007/978-3-030-27484-9doiSubjects--Topical Terms:

583819
Pharmacology.

LC Class. No.: RM1-950

Dewey Class. No.: 615

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