by PROTOCOL OF PERFORMANCE QUALIFICATION (PQ) OF UV-VIS UV- VIS SPECTROPHOTOMETER
Equipment ID No: ———–
(Location: Quality Control)
PROTOCOL CONTENTS
S. No. SECTION TITLE
- Protocol Approval
2.0 Overview
2.1 Objective
2.2 Purpose and Scope
2.3 Responsibility
- Qualification Team
3.0 System/Instrument Description.
4.0 Qualification Procedure and Acceptance criteria
4.1 Performance Qualification
4.2 Service Contact Address
4.3 Training
5.0 Qualification Report
6.0 Observed Deviation
7.0 Approval of Qualification Report
8.0 List of Exhibits/Annexure
8.1 List of Annexure
1.0 PROTOCOL APPROVAL
This is a specific protocol for Performance Qualification of UV-Vis spectrophotometer, used for testing of qualitative and quantitative analysis of in process/finished pharmaceutical product.
Approval
This Qualification Protocol shall be signed by the following:
Approval of this protocol will be joint responsibility of the following functional areas.
| Functional area | Name | Signature | Date |
| Quality Control | |||
| Quality Assurance |
This Performance Qualification protocol shall be approved by Quality Assurance personnel.
- OVERVIEW
- Purpose & Scope:
To verify that the UV-Vis spectrophotometer (Make—————) Instrument ID No. ———— received matches the intended requirements of Q.C laboratory for the use of qualitative and quantitative analysis for drug substance/ drug product.
2.2 Responsibility:
Quality Control officer/Executive
Quality Control Manager
2.3 Qualification Team:
Quality Control Officer, Quality Control Executive & Quality Control Tr. Chemist.
Quality Control Manager
Quality Assurance executive
3.0 System / Instrument Description
System / Instrument Details
- Instrument Identification Number :
- Location :
- Name of the System / Instrument :
- Make :
- Model :
4.0 QUALIFICATION PROCEDURE
4.1 Installation Qualification
Performed by the supplier – Report No. ——– .
4.2 Operation Qualification
Performed by the supplier – Report No. ——– .
4.3 Performance Qualification
As an evidence of satisfactory performance of UV-Vis spectrophotometer , The test solution of assay prepared as per pharmacopoeia or specific product specification, then scan the test solution in range between 200 nm and 400 nm and found a maximum absorbance in particular wavelength, then take a absorbance at about wavelength found in scan, that procedure perform on both uv and compare the results as per acceptance criteria and data to be enclosed in qualification report .
Acceptance Criteria
Test limit/ parameters shall be complies with acceptance criteria to standard testing procedure and result should meet the specification. The overall difference from the original result should not more than ± 1.0% for assigned test.
4.5 Training Record
Purpose: This purpose of the training is to familiarize the trainees/participants with overall strategy of Operation of UV-Vis spectrophotometer.
Training record shall be attached with the report .
5.0 Qualification Report:
Qualification report shall consist of a summary document, in narrative form, which briefly describes the work as well as conditions regarding acceptability.
This report shall also include related documents which were completed at the time of qualification activity.
6.0 Observed Deviations
Any deviation from the acceptance criteria shall be reported and decision shall be take for rejection, replacement or rectification of the equipment/component.
Any Deviation from the acceptance criteria will be recorded and attached with the report .
7.0 Approval of Qualification Report
The report shall be evaluated and proper references/conclusions/recommendations shall be recorded by quality control.
The Qualification report shall be evaluated and finally approved by quality assurance.
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