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

By: Contributor(s): Resource type: Ressourcentyp: Buch (Online)Book (Online)Language: English Series: AAPS Introductions in the Pharmaceutical Sciences | Springer eBook Collection | SpringerLink BücherPublisher: Cham : Springer International Publishing, 2018Description: Online-Ressource (XIV, 92 p. 54 illus., 37 illus. in color, online resource)ISBN:
  • 9783030024727
Subject(s): Additional physical formats: 9783030024710 | 9783030024734 | Erscheint auch als: 978-3-030-02471-0 Druck-Ausgabe | Printed edition: 9783030024710 | Printed edition: 9783030024734 DDC classification:
  • 615.19
LOC classification:
  • RS380 RS190-210
  • RS380
  • RS190-210
DOI: DOI: 10.1007/978-3-030-02472-7Online resources: Summary: 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, it is essential information for pharmaceutical professionals who use the process validation lifecycle approachSummary: 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 Process Qualifications -- Stage 3A and 3B: Continued Process VerificationPPN: PPN: 1041332807Package identifier: Produktsigel: ZDB-2-SBL | ZDB-2-SEB | ZDB-2-SXB
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Reproduktion. (Springer eBook Collection. Biomedical and Life Sciences)

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