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:
- Validation Coordinator
All validation activities through the different progress steps should be coordinated by one person, preferably the Quality assurance manager. - 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: - 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) - 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