Standard Operating Procedure for Validating the Coding Machine in Packaging

Purpose

The purpose of this SOP is to establish a standardized approach for the validation of the Coding Machine used for printing batch and expiry information on packaging for sterile powders and lyophilized products.

Scope

This SOP applies to the validation of the Coding Machine located in the packaging area, impacting the direct quality of the product.

Definitions

• Validation: A documented process that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
• Criticality: The level of impact that the equipment has on product quality.
• CSV: Computer System Validation.

Roles

• Validation Team: Responsible for executing and documenting the validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
• Operations: Utilizes the equipment and provides feedback on performance.

Lifecycle Procedure

1. Design Qualification (DQ): Ensure that the Coding Machine meets the requirements of the User Requirements Specification (URS).
2. Installation Qualification (IQ): Verify that the equipment is installed correctly and according to manufacturer specifications.
3. Operational Qualification (OQ): Confirm that the equipment operates as intended under simulated conditions.
4. Performance Qualification (PQ): Validate that the equipment consistently performs its intended function in a production environment.

GDP Controls

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

Acceptance Criteria Governance

Acceptance criteria will be established based on the URS Annex 11 and must be met during each qualification phase.

Calibration/PM Governance

The Coding Machine must be calibrated and maintained according to the manufacturer’s specifications and internal procedures. Calibration records must be kept up to date.

Change Control Triggers

Any changes to the equipment, process, or related documentation must undergo a formal change control process to assess the impact on validation status.

Revalidation Triggers and Periodic Review

The Coding Machine will require revalidation every 12 months or upon significant changes to the equipment or processes that may affect its performance.

Records/Attachments List

• User Requirements Specification (URS)
• Validation Protocols and Reports
• Calibration Records
• Change Control Documentation
• Periodic Review Records