Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the validation requirements for the Rapid Mixer Granulator (RMG) utilized in the production of solid dosage forms through wet granulation.

Scope

This SOP applies to the validation of the RMG equipment located in the Production/Granulation area and is relevant to all personnel involved in equipment validation activities.

Definitions

• RMG: Rapid Mixer Granulator, a critical piece of equipment used for wet granulation.
• Validation: The process of demonstrating that a procedure, process, or activity will consistently lead to the expected results.
• CSV: Computerized System Validation, required for systems that are computerized.

Roles

• Validation Team: Responsible for planning and executing the validation process.
• Quality Assurance: Ensures compliance with regulatory requirements and validation protocols.
• Production Personnel: Operate the RMG and provide input during the validation process.

Lifecycle Procedure

1. Design Qualification (DQ): Verify that the RMG is designed to meet user requirements.
2. Installation Qualification (IQ): Confirm that the RMG is installed correctly and according to specifications.
3. Operational Qualification (OQ): Assess the performance of the RMG under normal operating conditions.
4. Performance Qualification (PQ): Validate that the RMG consistently produces acceptable results.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process. All records must be clear, legible, and maintained in a manner that facilitates easy retrieval.

Acceptance Criteria Governance

Acceptance criteria for validation activities will be based on the User Requirement Specification (URS) and Annex 11 of the relevant regulatory guidelines.

Calibration/PM Governance

The RMG must undergo regular calibration and preventive maintenance as per the established schedule to ensure it remains in a validated state.

Change Control Triggers

Any changes to the RMG, including hardware or software modifications, must initiate a change control process to assess the impact on validation status.

Revalidation Triggers and Periodic Review

Revalidation of the RMG is required every 24 months or whenever significant changes occur that may impact the equipment’s performance.

Records/Attachments List

• Validation Protocols
• Validation Reports
• Calibration Records
• Maintenance Logs
• Change Control Documentation
• Periodic Review Records