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: Pharmaceutical microbiological quality assurance and control
    sub title: practical guide for non-sterile manufacturing
  name:
    name part: Roesti, David
    name part: 1973-
    role:
      role term: editor.
  name:
    name part: Goverde, Marcel
    name part: 1967-
    role:
      role term: editor.
  type of resource: text
  genre: bibliography
  origin info:
    place:
      place term: nju
    date issued: 2020
    copyright date: 2020
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource (xxxv, 546 pages.)
  abstract: "This book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. It covers state-of-the-art microbiology quality assurance and control (QA / QC) tests as well as risk mitigation strategies so that the reader can implement these methodologies in a facility or laboratory to meet microbiology current good manufacturing practices (cGMPs). Also, the authors discuss developments in microbiological testing technology. They share their long experience in practicing microbiological QA/QC in large multinational pharmaceutical companies and present real-life complex cases involving tough decision making"--
  table of contents: Microbiological control strategy -- Microbial contamination risk assessment in non-sterile drug product manufacturing and risk mitigation -- Qualification of Microbiological laboratory personnel and equipment -- Introduction to culture media in pharmaceutical microbiology for non-sterile products -- Microbiological examination of non-sterile final dosage forms and raw material including acceptance criteria and testing frequency -- Microbial requirements and testing of primary packaging -- Utilities design and testing -- Microbiological Environmental Monitoring -- Identification of microorganisms -- Calculating alert levels and trending of microbiological data -- Exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products -- Data integrity and microbiological excursion handling -- Rapid microbiological methods -- Validation of a rapid microbiological method for the microbiological examination of non-sterile and non-filterable drug products, APIs and excipients -- An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries -- Practical guide for microbiological QA/QC of non-sterile pharmaceuticals manufacturing for EU -- Which microbiological tests can better be performed in-house and what can be easily outsourced
  note: edited by David Roesti, Marcel Goverde.
  note: Includes bibliographical references and index.
  subject:
    topic: Pharmaceutical chemistry
  subject:
    topic: Drugs
    topic: Testing
  subject:
    topic: Quality control
  subject:
    topic: Technology, Pharmaceutical
    topic: standards
  subject:
    topic: Microbiological Techniques
    topic: standards
  subject:
    topic: Microbiological Phenomena
  subject:
    topic: Quality Control
  subject:
    topic: Drug Contamination
    topic: prevention & control
  subject:
    topic: Chemistry, Pharmaceutical
  classification: RS403 .P43 2020
  classification: 615.1/9
  classification: QV 778
  related item:
    identifier: (DLC) 2019024995
  identifier: 9781119356196 (electronic bk.)
  identifier: 1119356199 (electronic bk.)
  identifier: 9781119356073
  identifier: 1119356075
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: NhCcYBP
    record creation date: 230502
    record change date: 20260214201409.3
    record identifier: in00004685661
    language of cataloging:
      language term: eng