Design Qualification Protocol for Tablet Compression Machine

Document Control Number: DQ-OSD-001

Version: 1.0

Effective Date: 2023-10-01

Reviewed by: [Name]

Approval Date: [Date]

Objective

The objective of this Design Qualification (DQ) protocol is to ensure that the Tablet Compression Machine (Double Rotary) meets the specified requirements for its intended use in the production of solid dosage forms.

Scope

This protocol applies to the validation of the Tablet Compression Machine used in the production/compression area for high output tablet compression. It covers the critical aspects of the equipment’s design and functionality.

Responsibilities

The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with the defined acceptance criteria. The Quality Assurance (QA) team will review and approve the protocol and its results.

Prerequisites

Completion of User Requirement Specification (URS)
Installation Qualification (IQ) completion
Operational Qualification (OQ) completion

Equipment Description

The Tablet Compression Machine (Double Rotary) is designed for high output tablet production. It utilizes advanced technology for efficient compression of powders into tablets while maintaining product integrity and quality.

Test Plan

Test ID	Procedure	Acceptance	Evidence
T1	Verify speed control settings	Within specified limits as per URS	Calibration records
T2	Check force application during compression	Consistent with URS requirements	Test run data
T3	Validate weight control of tablets	Within acceptable weight range	Weight measurement logs
T4	Assess reject functionality	Rejects non-conforming tablets	Operational logs

Detailed Test Cases

Test Case T1: Verify Speed Control Settings

Procedure: Adjust the speed settings of the machine and verify against the URS specifications.

Acceptance Criteria: Speed settings must be within specified limits as per URS.

Evidence: Documented calibration records must be maintained.

Test Case T2: Check Force Application During Compression

Procedure: Conduct compression runs and measure the force applied during the process.

Acceptance Criteria: The force must be consistent with the requirements outlined in the URS.

Evidence: Test run data must be documented and reviewed.

Test Case T3: Validate Weight Control of Tablets

Procedure: Weigh a sample of tablets produced and compare against the specified weight range.

Acceptance Criteria: All tablets must fall within the acceptable weight range.

Evidence: Weight measurement logs must be maintained for review.

Test Case T4: Assess Reject Functionality

Procedure: Run the machine and assess its ability to reject non-conforming tablets.

Acceptance Criteria: The machine must effectively reject any tablets that do not meet specifications.

Evidence: Operational logs must be reviewed and documented.

Deviations

Any deviations observed during testing must be documented and assessed for impact on product quality and compliance. A deviation report must be generated and submitted for review.

Approvals

Prepared by: [Name]