(PQ) OF UV-VIS UV- VIS SPECTROPHOTOMETER

PQ OF UV-VISIBLE SPECTROPHOTOMETER

PROTOCOL OF PERFORMANCE QUALIFICATION (PQ) OF UV-VIS UV- VIS SPECTROPHOTOMETER

Equipment ID No: ———–

 (Location: Quality Control)

PROTOCOL CONTENTS

S. No.      SECTION TITLE

  1. 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.

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

View all posts by Bhanu Pratap Singh →

Leave a Reply

Your email address will not be published. Required fields are marked *

error: Content is protected !!