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QC reviewer qualification

QC reviewer qualification

This  eLearning  module is to test the ability of QC reviewer to identify errors in the records and improve assurance of the review process ​


  • Provide an overview of the review process for GMP data​

  • Revisits the requirement of effective review​

  • Common checks for data review​

  • Role of data reviewers​

  •  Assessing the capabilities of the reviewer to identify errors in sample records​

  • Why it matters​

    Since incorrectly manufactured, or tested medicines, if allowed to reach patients, can cause serious conditions, or even death, various health authorities require a confirmation that, these activities run correctly, during pharmaceutical manufacturing, and testing.


    For example, US FDA’s 21 CFR 211.194 have specific requirments for QC data review. 

  • Who is it for​

    Since production and testing records are the only proof that the activities were carried out correctly, such confirmation takes the form of verification, or review of the records.​

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