Standard Operating Procedure for Equipment Validation of Powder Compounding Vessel

Purpose: This SOP outlines the validation process for the Powder Compounding Vessel (Jacketed SS) used in the production of sachets and stick packs, ensuring compliance with regulatory requirements and product quality standards.

Scope: This procedure applies to the validation of the Powder Compounding Vessel utilized for preparing bulk powder blends or granulations intended for sachet filling in a non-sterile environment.

Definitions:

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

Roles:

• Validation Team: Responsible for the execution and documentation of the validation process.
• Quality Assurance: Ensures compliance with SOPs and regulatory standards.
• Production Personnel: Operate the equipment and provide necessary input during validation.

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 predefined limits.
4. Performance Qualification (PQ): Assess the equipment’s performance under actual production conditions.

GDP Controls: Good Documentation Practices must be adhered to at all stages of validation, ensuring all records