Pazhayattil Ajay Babu, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija Solid Oral Dose Process Validation: The Basics, Volume 1 9783030024710

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Автор: Pazhayattil Ajay Babu, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija
Название: Solid Oral Dose Process Validation: The Basics, Volume 1
ISBN: 9783030024710
Издательство: Springer
Классификация:

Фармакология

Аптечная служба и отпуск лекарственных средств

Промышленный дизайн

Промышленная химия

Технологии производства фармацевтических препаратов

ISBN-10: 3030024717
Обложка/Формат: Hardcover
Страницы: 92
Вес: 0.54 кг.
Дата издания: 10.12.2018
Серия: Aaps introductions in the pharmaceutical sciences
Язык: English
Издание: 1st ed. 2018
Иллюстрации: 10 tables, color; 37 illustrations, color; 17 illustrations, black and white; xiv, 92 p. 54 illus., 37 illus. in color.
Размер: 236 x 160 x 15
Читательская аудитория: Professional & vocational
Подзаголовок: The basics, volume 1
Ссылка на Издательство: Link
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Поставляется из: Германии
Описание: Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidances such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidances 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, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
Дополнительное описание: Volume One.Preface.- Lifestyle Approach to Validation.- Solid Dose Formulations.- Stage 1A Process Design: Quality by Design.- Knowledge Management and Risk Assessment for Lifestyle Stages.- .Stage 1B Process and Scale Up Considerations.- Stage 2A and 2B

Solid Oral Dose Process Validation: The Basics, Volume 1, Pazhayattil Ajay Babu, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija