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Titlebook: Solid Oral Dose Process Validation; The Basics, Volume 1 Ajay Babu Pazhayattil,Naheed Sayeed-Desta,Jordan C Book 2018 American Association

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書目名稱Solid Oral Dose Process Validation
副標(biāo)題The Basics, Volume 1
編輯Ajay Babu Pazhayattil,Naheed Sayeed-Desta,Jordan C
視頻videohttp://file.papertrans.cn/872/871534/871534.mp4
概述First publication to address process validation and the lifecycle process.Essential information for pharmaceutical professional who use process lifecycle validation.Addresses the need for consensus an
叢書名稱AAPS Introductions in the Pharmaceutical Sciences
圖書封面Titlebook: Solid Oral Dose Process Validation; The Basics, Volume 1 Ajay Babu Pazhayattil,Naheed Sayeed-Desta,Jordan C Book 2018 American Association
描述.Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory?guidance‘s such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance‘s and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance..?Solid Dose Process Validation: The Basics, Volume One?.and companion?.Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, .also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet?the regulatory requirements enlisted in the guidance’s, which is the precursor to?applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations?encompass majority of the pharmaceutical preparations,
出版日期Book 2018
關(guān)鍵詞solid dose manufacturing; QbD pharma; Stage 2A and 2B PPQ; CPV requirements; ICH Risk Assessment; Pharma
版次1
doihttps://doi.org/10.1007/978-3-030-02472-7
isbn_ebook978-3-030-02472-7Series ISSN 2522-834X Series E-ISSN 2522-8358
issn_series 2522-834X
copyrightAmerican Association of Pharmaceutical Scientists 2018
The information of publication is updating

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Solid Dose Formulations, and capsule formulations and the traditional manufacturing processes. New technologies such as 3D printing are currently emerging as an alternate manufacturing process. Continuous solid dose manufacturing utilizes technology such as process analytical technology (PAT), process modeling to enhance pharmaceutical solid dose manufacturing processes.
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AAPS Introductions in the Pharmaceutical Scienceshttp://image.papertrans.cn/s/image/871534.jpg
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forms between inputs and outputs are performed. By adaptive I mean that the element can change in some systematic manner and in so doing alter the transform between input and output. In living systems, transmission within the neural network involves cpded nerve impulses and other physical chemical p
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