Purpose

The purpose of this SOP is to establish a standardized approach for the validation of automatic capsule filling machines used in the production of solid dosage forms, ensuring compliance with regulatory requirements and product quality standards.

Scope

This SOP applies to all automatic capsule filling machines utilized in the production area for capsule filling processes within the facility.

Definitions

• Validation: The process of establishing documented evidence that a system operates as intended.
• Criticality: The importance of the equipment in the production process, influencing product quality and safety.
• CSV: Computerized System Validation, ensuring that computerized systems are fit for their intended use.

Roles

• Validation Team: Responsible for planning and executing validation activities.
• Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
• Production Personnel: Operate the equipment and provide feedback on performance.

Lifecycle Procedure

1. Design Qualification (DQ): Ensure that the design meets the user requirements.
2. Installation Qualification (IQ): Verify that the equipment is installed correctly and operates according to specifications.
3. Operational Qualification (OQ): Confirm that the equipment operates within specified limits under normal operating conditions.
4. Performance Qualification (PQ): Validate that the equipment consistently produces a product that meets predetermined specifications.

Good Documentation Practices (GDP) Controls

All validation documents must be completed in accordance with Good Documentation Practices, ensuring clarity, accuracy, and traceability.

Acceptance Criteria Governance

Acceptance criteria for validation activities will be governed by the User Requirements Specification (URS) as per Annex 11 of the applicable regulations.

Calibration and Preventive Maintenance (PM) Governance

Calibration and PM activities must be conducted as per the established schedule to ensure equipment remains in a validated state. Documentation of these activities must be maintained.

Change Control Triggers

Any changes to the equipment, processes, or software that may impact the validated state must initiate a change control process, including revalidation if necessary.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or whenever significant changes occur that could affect the equipment’s performance or the quality of the product.

Records and Attachments List

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