A Detailed Case Study on Deviation, Out-of-Specification(OOS) and CAPA Generation in Pharmaceutical Industry

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Abstract

This review provide an overview of the various documentation of quality management system, which includes deviations, OOS and CAPA. A detailed case study of deviations, out-of-Specification and CAPA generation is beneficial for improving pharmaceutical capabilities and understanding the documentation associated with a quality management system. It is essential for understanding deviations and out-of-spec in the pharmaceutical industry. The quality of medicines means that they meet the required specifications. The quality management system in the pharmaceutical industry is essential because the drugs or pharmaceutical products are delivered directly to the customer's body. Therefore, identity, purity, safety,…

Citation impact

959
total citations
FWCI
477.15
Percentile
100%
References
23
Citations per year

Authors

4

Topics & keywords

Keywords
  • Documentation
  • Pharmaceutical industry
  • Quality (philosophy)
  • Risk analysis (engineering)
  • Quality management system
  • Product (mathematics)
  • Root cause
  • Computer science
UN Sustainable Development Goals
  • Industry, innovation and infrastructure
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