Performance Qualification Protocol for Colloid Mill Used in Nasal & Otic Product Production
Document ID: PQ-CM-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Colloid Mill used in the production of Nasal and Otic products to ensure it effectively reduces particle size to meet specified criteria.
Scope
This protocol applies to the Colloid Mill utilized in the production area for the manufacturing of both sterile and non-sterile Nasal and Otic products.
Responsibilities
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for operating the Colloid Mill and providing necessary support during validation.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ) for the Colloid Mill.
- Availability of all necessary materials and equipment for testing.
- Training of personnel on the operation of the Colloid Mill.
Equipment Description
The Colloid Mill is designed to reduce particle size through the use of mechanical shear forces. It is equipped with adjustable gap settings to control the particle size effectively.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-CM-01 | Measure particle size before and after milling at different gap speeds. | Particle size must be reduced to specified limits as per URS. | Particle size analysis report. |
Detailed Test Cases
Test Case 1: Particle Size Reduction
1. Set the Colloid Mill to the first gap speed setting.
2. Process the sample for a specified duration.
3. Collect the sample and analyze the particle size using a particle size analyzer.
4. Document the results and compare with the acceptance criteria.
Test Case 2: Repeatability
1. Repeat the particle size reduction test three times at the same gap speed.
2. Document each result.
3. Calculate the average particle size and standard deviation to assess consistency.
Deviations
Any deviations from the protocol must be documented and justified. If acceptance criteria are not met, re-evaluation of the process and equipment may be necessary.
Approvals
All results must be reviewed and approved by the Quality Assurance team before the equipment can be deemed qualified for production use.