Standard Operating Procedure for the Validation of Roller Compactors

Purpose

This SOP outlines the validation process for Roller Compactors used in the production of solid dosage forms through dry granulation, ensuring compliance with regulatory standards and product quality.

Scope

This procedure applies to all Roller Compactors utilized in the production area for dry granulation within the pharmaceutical manufacturing facility.

Definitions

• Equipment Validation: The process of ensuring that equipment consistently produces a product meeting its predetermined specifications and quality attributes.
• Critical Equipment: Equipment that has a direct impact on product quality.
• CSV: Computerized System Validation, ensuring that computerized systems operate as intended.

Roles

• Validation Team: Responsible for planning, executing, and documenting validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and approves validation documentation.
• Maintenance Team: Responsible for equipment maintenance and calibration.

Lifecycle Procedure

1. Design Qualification (DQ): Verify that the Roller Compactor is designed to meet user requirements.
2. Installation Qualification (IQ): Confirm that the equipment is installed according to manufacturer specifications.
3. Operational Qualification (OQ): Ensure that the equipment operates within specified limits under normal operating conditions.
4. Performance Qualification (PQ): Validate that the equipment consistently produces the desired output quality.

GDP Controls

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

Acceptance Criteria Governance

Acceptance criteria will be established based on User Requirement Specifications (URS) and Annex 11 guidelines to ensure compliance with regulatory expectations.

Calibration/PM Governance

Regular calibration and preventive maintenance (PM) must be performed according to the manufacturer’s recommendations and documented accordingly.

Change Control Triggers

Any changes to equipment, processes, or materials that may impact the validated state of the Roller Compactor must trigger a change control process.

Revalidation Triggers and Periodic Review

Revalidation is required every 24 months or when significant changes occur in equipment, processes, or product formulations.

Records/Attachments List

• Validation Protocols
• Validation Reports
• Change Control Records
• Calibration and Maintenance Records
• Training Records