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.

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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