Purpose

This SOP establishes the process for validating the Suppository Base Melting Vessel (Jacketed SS) to ensure consistent performance in the production of cocoa butter-based suppositories.

Scope

This procedure applies to the validation of the Suppository Base Melting Vessel used in the Production area for the melting of polyethylene glycol (PEG) suppository bases.

Definitions

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

Roles

• Validation Team: Responsible for executing the validation protocol.
• Quality Assurance: Oversees compliance and approval of validation documentation.
• Production Personnel: Operate the equipment and provide input on performance.

Lifecycle Procedure

1. Conduct Design Qualification (DQ).
2. Complete Installation Qualification (IQ).
3. Perform Operational Qualification (OQ).
4. Execute Performance Qualification (PQ).
5. Document all findings and obtain necessary approvals.

Good Documentation Practices (GDP) Controls

All validation documents must be completed in accordance with Good Documentation Practices to ensure accuracy and traceability.

Acceptance Criteria Governance

Acceptance criteria for all validation phases must be established and documented, with a review period of 12 months.

Calibration and Preventive Maintenance Governance

The Suppository Base Melting Vessel must undergo regular calibration and preventive maintenance as per the established schedule.

Change Control Triggers

Any changes to the equipment, process, or materials used must trigger a change control process to assess the impact on validation status.

Revalidation Triggers and Periodic Review

Revalidation is required if there are significant changes to the equipment or processes. A periodic review must be conducted at least annually.

Records and Attachments List

• Validation Protocols
• Validation Reports
• Calibration Records
• Preventive Maintenance Logs
• Change Control Documentation