Purpose

This Standard Operating Procedure (SOP) outlines the validation process for the HVAC System used in the production of suppositories and implants, ensuring compliance with regulatory requirements and product quality standards.

Scope

This SOP applies to the HVAC System categorized as a utility equipment used in the production area for suppositories and implants.

Definitions

• HVAC System: A system that controls temperature, humidity, and pressure in the production environment.
• Validation: The process of demonstrating that a system consistently produces a result meeting predetermined specifications.
• Criticality: The importance of the equipment in relation to product quality; in this case, classified as indirect.

Roles

• Validation Team: Responsible for executing the validation process and ensuring compliance.
• Quality Assurance: Oversees the validation process and ensures adherence to regulatory standards.
• Maintenance Personnel: Responsible for calibration and preventive maintenance of the HVAC system.

Lifecycle Procedure

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

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are complete, accurate, and up-to-date.

Acceptance Criteria Governance

Acceptance criteria will be based on temperature, humidity, and pressure cascade audit trail logs, ensuring all parameters remain within specified limits throughout production.

Calibration/PM Governance

Regular calibration and preventive maintenance (PM) must be conducted according to the manufacturer’s specifications and documented in the maintenance logs.

Change Control Triggers

Any changes to the HVAC system, including modifications to its operation or maintenance procedures, must be documented and assessed for impact on validation status.

Revalidation Triggers and Periodic Review

Revalidation is required if there are significant changes to the system or its operating environment. A periodic review must be conducted at least annually to ensure continued compliance.

Records/Attachments List

• Validation Protocols
• Calibration Certificates
• Maintenance Logs
• Audit Trail Logs
• Change Control Records