Responsibilities of the Validation Team to Meet the cGMP Compliance

Purpose: The purpose is to describe the responsibility and functions of the validation team to meet the cGMP compliance
Responsibility: It is the responsibility of all concerned departments to follow the procedure. The QA manager is responsible for compliance.


  1. Validation Coordinator
    All validation activities through the different progress steps should be coordinated by one person, preferably the Quality assurance manager.
  2. Validation Task Force/Certification Team
    The team should consist of managers of the departments involved in the validation and outside vendors (if applicable); for example:
    • Quality assurance manager
    • Production manager
    • Technical services manager
    • Product development manager
    • Calibration manager
    • Quality control manager
    • Approved vendors (outside)
    2.1 Responsibilities
    • Scope of validation
    • Validation priorities
    • Acceptance criteria
    • Approving of validation protocols and reports
    • Validation change control
    SOP No. Effective date: mm/dd/yyyy
    Approved by:
  3. Validation Working Groups
    The executive part of the validation work should be delegated to dedicated personnel:
    • A member of the validation task force
    • Representatives from relevant departments
    • A representative from quality assurance
    • A representative from technical services
    • A representative from the product development laboratory
    • A representative from quality control
    • A representative from the vendor (outside)
  4. Validation Planning and Scheduling
    • Manpower resources
    • Document preparation
    • Filed execution
    • Calibration
    • Lab support
    • Test and balance/filter certification
    • Start-up and commissioning

Related Post: Fundamentals of Validation SOP

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