Standard Operating Procedure for the Validation of Solvent Storage Tanks

Purpose

This SOP outlines the procedures for the validation of Solvent Storage Tanks used in the production of APIs, ensuring compliance with regulatory requirements and maintaining product quality.

Scope

This SOP applies to all Solvent Storage Tanks (SS / GL) utilized in the API manufacturing area for solvent storage within the production facility.

Definitions

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• CSV: Computerized System Validation

Roles

The following roles are involved in the validation process:

• Validation Team: Responsible for executing and documenting the validation activities.
• Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
• Production Manager: Oversees the operation and maintenance of the Solvent Storage Tanks.

Lifecycle Procedure

1. Design Qualification (DQ): Verify that the design meets user requirements.
2. Installation Qualification (IQ): Confirm that the equipment is installed correctly and according to specifications.
3. Operational Qualification (OQ): Validate that the equipment operates within specified limits.
4. Performance Qualification (PQ): Ensure the equipment performs as intended in a production environment.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process to ensure traceability and compliance. All records should be complete, legible, and signed by the responsible personnel.

Acceptance Criteria Governance

Acceptance criteria for validation activities will adhere to the guidelines outlined in URS Annex 11 and Annex 15, ensuring that all critical aspects of the equipment are validated.

Calibration/PM Governance

Regular calibration and preventive maintenance (PM) must be performed on the Solvent Storage Tank to ensure ongoing compliance and functionality, as per the manufacturer’s recommendations.

Change Control Triggers

Any changes to the Solvent Storage Tank, including modifications to design, operation, or maintenance procedures, will trigger a re-evaluation of the validation status.

Revalidation Triggers and Periodic Review

Revalidation will occur every 12 months or whenever significant changes are made to the equipment or process. A periodic review of the validation documentation will also be conducted to ensure continued compliance.

Records/Attachments List

• Validation Protocols
• Validation Reports
• Calibration and PM Records
• Change Control Documentation
• Periodic Review Documentation