Operational Qualification Protocol for Tablet Compression Machine

Objective

The objective of this Operational Qualification (OQ) protocol is to verify that the Tablet Compression Machine operates within specified parameters and meets the acceptance criteria outlined in the User Requirement Specification (URS) Annex11.

Scope

This protocol applies to the Tablet Compression Machine (Single Rotary) used in the production area for tablet compression of solid dosage forms. It encompasses the validation of critical parameters impacting product quality.

Responsibilities

The following personnel are responsible for executing this protocol:

• Validation Engineer: Responsible for protocol execution and data analysis.
• Quality Assurance: Responsible for review and approval of the protocol and results.
• Production Supervisor: Ensures that the equipment is set up correctly and operational during testing.

Prerequisites

Prior to execution of this OQ protocol, the following must be completed:

• Installation Qualification (IQ) must be completed and approved.
• All necessary training for personnel must be conducted.
• The equipment must be calibrated and maintained per the manufacturer’s specifications.

Equipment Description

The Tablet Compression Machine (Single Rotary) is designed for tablet compression in solid dosage form production. It operates using a programmable logic controller (PLC) to manage critical parameters such as speed, compression force, and weight control.

Test Plan

Detailed Test Cases

Test Case OQ-001: Verify Speed

Procedure: Set the machine to the specified speed and record the actual speed using a tachometer. Compare the recorded speed to the acceptance criteria.

Acceptance Criteria: Speed must be within ±5% of the target.

Evidence: Calibration report and tachometer readings.

Test Case OQ-002: Verify Compression Force

Procedure: Adjust the compression force to the required setting and measure the force using a force gauge. Compare the measured force to the acceptance criteria.

Acceptance Criteria: Compression force must be within specified limits as per URS.

Evidence: Force measurement log and gauge calibration certificate.

Test Case OQ-003: Verify Weight Control

Procedure: Conduct weight checks on a sample of compressed tablets and record the weights. Compare the results to the acceptance criteria.

Acceptance Criteria: Weight variation must not exceed ±5% of the target weight.

Evidence: Weight control log and statistical analysis report.

Deviations

Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be developed and executed as necessary.

Approvals

This protocol must be approved by the following individuals:

• Validation Engineer: ____________________ Date: __________
• Quality Assurance: ____________________ Date: __________
• Production Supervisor: ____________________ Date: __________

Data Integrity Checks

As CSV is required, ensure the following data integrity checks are performed:

• Automated data logging for speed, force, and weight parameters.
• Regular backups of all electronic records.
• Audit trails for any changes made to the parameters or settings.