Performance Qualification Protocol for Multi Mill in Solid Dosage Form

Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Multi Mill used in Solid Dosage Form manufacturing, focusing on critical parameters and acceptance criteria.

Tags: Equipment Validation, Multi Mill, PQ Protocol, Solid Dosage Form, Production, Milling

Objective

The objective of this Performance Qualification (PQ) protocol is to validate the Multi Mill’s performance in milling and sizing powders/granules to ensure compliance with defined acceptance criteria.

Scope

This protocol applies to the Multi Mill used in the Production/Milling area for the direct impact on the product quality of solid dosage forms.

Responsibilities

• Validation Team: Responsible for executing the PQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the protocol and results.
• Production Team: Responsible for operating the Multi Mill as per the protocol.

Prerequisites

• Multi Mill installed and operational.
• Operators trained on equipment use.
• Standard Operating Procedures (SOPs) in place.

Equipment Description

The Multi Mill is a versatile equipment used for milling and sizing powders and granules in the pharmaceutical industry. It operates at variable rotor speeds and utilizes screens to achieve desired particle size distribution (PSD).

Test Plan

Detailed Test Cases

Test Case 1: Rotor Speed Measurement

Test ID: PQ-001

Procedure: Operate the Multi Mill at predetermined settings and measure the rotor speed using a calibrated tachometer.

Acceptance Criteria: Rotor speed must be within the specified range as per URS.

Evidence: Documented calibration report confirming rotor speed measurement.

Test Case 2: Screen Integrity Inspection

Test ID: PQ-002

Procedure: Visually inspect the screen before and after the milling process for any signs of damage or wear.

Acceptance Criteria: Screen must show no signs of damage or wear.

Evidence: Inspection log documenting the condition of the screen.

Test Case 3: Output PSD Analysis

Test ID: PQ-003

Procedure: Collect samples from the output and analyze for particle size distribution using appropriate analytical methods.

Acceptance Criteria: PSD must meet specifications as outlined in the URS.

Evidence: PSD analysis report detailing results.

Deviations

Any deviations from the established protocol must be documented and justified. A deviation report should be created and approved by the validation team and quality assurance.

Approvals

This protocol must be reviewed and approved by the appropriate stakeholders before execution.