Responsibilities of the Validation Team to Meet the cGMP Compliance

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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.

Procedure:

  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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