Standard Operating Procedure for Equipment Validation of Shaking Incubator
Purpose
The purpose of this SOP is to define the validation process for the Shaking Incubator used in cell culture growth within the Biologics Upstream Processing area.
Scope
This SOP applies to the validation of the Shaking Incubator utilized in the Production/Cell Culture area for biologics manufacturing.
Definitions
- SOP: Standard Operating Procedure
- CSV: Computer System Validation
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
Roles
Roles involved in the validation process include:
- Validation Manager
- Quality Assurance (QA) Personnel
- Production Staff
- Maintenance Personnel
Lifecycle Procedure
- Document Requirements Specification (URS) for the Shaking Incubator.
- Perform Design Qualification (DQ) to ensure equipment meets user requirements.
- Conduct Installation Qualification (IQ) to verify proper installation.
- Execute Operational Qualification (OQ) to confirm operational parameters.
- Complete Performance Qualification (PQ) to ensure equipment performs as intended.
GDP Controls
Good Documentation Practices (GDP) must be followed throughout the validation process to ensure traceability and compliance.
Acceptance Criteria Governance
Acceptance criteria will be governed by the User Requirements Specification (URS) and Annex 11 of the applicable regulations.
Calibration/PM Governance
The Shaking Incubator must be calibrated and maintained according to the manufacturer’s specifications and the internal maintenance schedule.
Change Control Triggers
Any modifications to the equipment, process, or associated documentation must initiate a change control process.
Revalidation Triggers and Periodic Review
Revalidation is required every 12 months or when significant changes occur that may impact equipment performance.
Records/Attachments List
- User Requirements Specification (URS)
- Validation Protocols (DQ/IQ/OQ/PQ)
- Calibration Records
- Change Control Documentation
- Periodic Review Reports