Standard Operating Procedure for the Validation of Weighing Balances in Solid Dosage Form

Purpose: This SOP outlines the validation process for weighing balances used in the production and dispensing of solid dosage forms, ensuring compliance with regulatory requirements and maintaining product quality.

Scope: This procedure applies to all weighing balances (platform/floor type) utilized in the production and dispensing areas for weighing raw materials (RM) and intermediate bulk containers (IBCs).

Definitions:

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• GDP: Good Documentation Practices

Roles:

• Validation Team: Responsible for the development and execution of the validation protocol.
• Quality Assurance: Ensures compliance with SOPs and regulatory requirements.
• Production Staff: Operates the weighing balances and ensures adherence to validated procedures.

Lifecycle Procedure:

1. Design Qualification (DQ): Document requirements and specifications for the weighing balance.
2. Installation Qualification (IQ): Verify that the equipment is installed according to manufacturer specifications.
3. Operational Qualification (OQ): Test the equipment under normal operating conditions to ensure it meets operational specifications.
4. Performance Qualification (PQ): Confirm that the equipment consistently performs as intended in the production environment.

GDP Controls: All documentation related to the validation process must adhere to Good Documentation Practices, ensuring accuracy, clarity, and traceability.

Acceptance Criteria Governance: Acceptance criteria for the validation of the weighing balance will follow the guidelines established in the URS SOP Calibration.

Calibration/PM Governance: Weighing balances must be calibrated and maintained according to the manufacturer’s recommendations and the established calibration schedule.

Change Control Triggers: Any changes to the weighing balance, including software updates or hardware modifications, require a change control assessment and may necessitate revalidation.

Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or whenever significant changes occur in the equipment, process, or product.

Records/Attachments List:

• Validation Protocols
• Calibration Certificates
• Change Control Documents
• Training Records
• Periodic Review Reports