rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Solid Oral Dose Process Validation, Volume Two
    sub title: Lifecycle Approach Application
  name:
    name part: Pazhayattil, Ajay.
    role:
      role term: creator
    role:
      role term: author.
    role:
      role term: aut
    role:
      role term: http://id.loc.gov/vocabulary/relators/aut
  name:
    name part: Sayeed-Desta, Naheed.
    role:
      role term: author.
    role:
      role term: aut
    role:
      role term: http://id.loc.gov/vocabulary/relators/aut
  name:
    name part: Fredro-Kumbaradzi, Emilija.
    role:
      role term: author.
    role:
      role term: aut
    role:
      role term: http://id.loc.gov/vocabulary/relators/aut
  name:
    name part: Ingram, Marzena.
    role:
      role term: author.
    role:
      role term: aut
    role:
      role term: http://id.loc.gov/vocabulary/relators/aut
  name:
    name part: Collins, Jordan.
    role:
      role term: author.
    role:
      role term: aut
    role:
      role term: http://id.loc.gov/vocabulary/relators/aut
  name:
    name part: SpringerLink (Online service)
  type of resource: text
  origin info:
    place:
      place term: gw
    date issued: 2019
    edition: 1st ed. 2019.
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: electronic
    form: electronic resource
    reformatting quality: access
    form: remote
    extent: XII, 108 p. 83 illus., 60 illus. in color. online resource.
  abstract: 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.
  table of contents: 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.
  note: by Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins.
  subject:
    topic: Pharmacology
  subject:
    topic: Pharmacy
  subject:
    topic: Pharmacology/Toxicology
  subject:
    topic: Pharmacy
  classification: RM1-950
  classification: 615
  related item:
    title info:
      title: Springer eBooks
  related item:
    title info:
      title: AAPS Introductions in the Pharmaceutical Sciences
  identifier: 9783030274849
  identifier: https://doi.org/10.1007/978-3-030-27484-9
  record info:
    record creation date: 190830
    record change date: 20191027121129.0
    record identifier: 978-3-030-27484-9