Standard Operating Procedure for Validation of Capper Equipment in Solid Dosage Form

Purpose

The purpose of this SOP is to establish a standardized approach for the validation of Capper (Screw Cap) equipment used in the packaging of solid dosage forms, ensuring compliance with regulatory requirements and product quality standards.

Scope

This SOP applies to the validation of Capper (Screw Cap) equipment utilized in the Packaging/Primary area for the purpose of capping bottles in the manufacturing of solid dosage forms.

Definitions

• Capper (Screw Cap): Equipment used to securely seal bottles with screw caps.
• Validation: A documented process for obtaining, providing, and documenting evidence that a system or process meets its intended use.
• Criticality: The impact of equipment failure on product quality and patient safety.

Roles

• Validation Team: Responsible for planning and executing the validation process.
• Quality Assurance: Ensures compliance with regulatory standards and oversees validation documentation.
• Maintenance Team: Conducts preventive maintenance and calibration of the equipment.

Lifecycle Procedure

1. Design Qualification (DQ): Verify that the equipment design meets user requirements.
2. Installation Qualification (IQ): Confirm that the equipment is installed according to specifications.
3. Operational Qualification (OQ): Assess the equipment’s operational performance under normal conditions.
4. Performance Qualification (PQ): Validate the equipment’s performance with actual product under production conditions.

GDP Controls

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

Acceptance Criteria Governance

Acceptance criteria will be established based on User Requirement Specifications (URS) and Annex 11 of the regulatory guidelines to ensure compliance and product quality.

Calibration/PM Governance

Calibration and preventive maintenance (PM) of the Capper (Screw Cap) equipment must be conducted in accordance with the established schedule and documented in the maintenance log.

Change Control Triggers

Any significant changes to the equipment, process, or product must initiate a change control process to assess the impact on validation status.

Revalidation Triggers and Periodic Review

Revalidation of the Capper (Screw Cap) equipment is required every 12 months or following any significant change to the equipment or process.

Records/Attachments List

• Validation Protocols
• Validation Reports
• Calibration and Maintenance Records
• Change Control Documentation
• User Requirement Specifications (URS)