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TEMPLATE FOR PERFORMACE QUALIFICATION PROTOCOL

TEMPLATE FOR PERFORMANCE QUALIFICATION PROTOCOL

CONTENTS

Topic No. Topic Page No.
Protocol Preparation and Approval 2
1.0 Objective 3
2.0 Scope 3
3.0 Responsibility 3
4.0 Abbreviations & Definitions 3
5.0 Brief Description of Equipment 4
6.0 Pre-requisites 4
7.0 Validation Procedure 4
8.0 Recording/ Data compilation 5
9.0 Deviations and Investigations 5
10.0       Qualification/ Validation Report Preparation 5
11.0       Re-validation/Re-qualification of Equipment 5
12.0       Reference 5

 

                                    Protocol Preparation and Approval

Preparation and Checking:

  Validation Team
Prepared by Checked by
Department Quality Assurance Quality Control Production Production Quality Control Quality Assurance
Name
Signature
Date

 

 Approval:

  Approved by
Head-Production Head- Quality Control Head- Quality Assurance
Name
Signature
Date

   

  • OBJECTIVE

To describe the Performance Qualification procedure to be used during qualification of NAME OF THE EQUIPMENT system in order to:

  • ensure the system reproducibility over an appropriate time period as per user requirement specifications No.
  • Ensure that the system is showing consistency in producing Product of pre-established specifications.
  • SCOPE

This procedure applies to the Performance Qualification of NAME OF THE EQUIPMENT installed in pharmaceutical Company Name with Location.

  • RESPONSIBILITY
    • Validation team shall be responsible for the preparation and checking of the Performance Qualification/Validation protocol.
    • Head-Production, Head-Quality Control & Head-Quality Assurance shall be responsible for the approval of Performance Qualification protocol.
    • Head -Quality Control shall be responsible for facilitating analysis of samples,            evaluations of the test results.
    • Production Department shall be responsible for compilation of validation data.
    • Head -Quality Assurance shall be responsible for approval of the Performance Qualification Report and certification after successful qualification of Equipment. 
  • ABBREVIATIONS AND DEFINITIONS

PQ:      Performance Qualification; documented verification that the integrated system or subsystem             functions as intended, in its normal operating environment.

DQ:     Design Qualification.

IQ:       Installation Qualification.

OQ:     Operational Qualification

Validation Team:        Trained representatives from Quality Assurance, Quality Control, and Engineering and Production departments participating in validation. For NAME OF THE EQUIPMENT, the validation team members shall enlist their names & signatures.

  • BRIEF DESCRIPTION OF NAME OF THE EQUIPMENT : 
Equipment ID No.  
Name of the Supplier  
Capacity  
Location  

 

  • PRE-REQUISITES

Before validating the NAME OF THE EQUIPMENT following should be ensured:

  • Successful completion of Operational Qualification of NAME OF THE EQUIPMENT – as per Protocol.
  • Availability of Test Protocols
  • Availability of following SOP(s)
    • Operation of NAME OF THE EQUIPMENT, SOP No
    • Cleaning of NAME OF THE EQUIPMENT, SOP No
  • VALIDATION PROCEDURE

Performance of the NAME OF THE EQUIPMENT shall be checked by carrying out ‘3’ batches of ‘1’ product as per their respective BMR.

Following are the critical process and quality parameters shall be noted down during the execution of the batches.

Sampling plan shall be as per the first three Process validation protocol. 

  • RECORDING/ DATA COMPILATION

During validation study the Data from each phase shall be compiled by Validation Team.

  • DEVIATIONS AND INVESTIGATIONS

In case there is any deviation followed during any stage of validation, corrective action shall be    taken after proper investigation. Deviations shall be recorded in Annexure-.

  • QUALIFICATION/ VALIDATION REPORT PREPARATION

After completion of validation, a report shall be prepared by the validation team members supported with tabulated data and statistical analysis (trending and graphical presentation of data if applicable). Performance Qualification Report shall include various components compiled in following sequence: (Note: The following components are attached as separate annexure.

  • Validation Report cover page
  • Index page for Validation Report
  • Approval Sheet
  • Name of validation team members
  • Parameter recording sheet
  • Deviations and Investigations, if any
  • Qualification Reports
  • Certification of completion of validation
  • RE-VALIDATION/ RE-QUALIFICATION CRITERIA

After completion of Performance qualification study, frequency of re-qualification or re-validation of NAME OF THE EQUIPMENT shall be fixed. Moreover the NAME OF THE EQUIPMENT shall invite revalidation as and when any major modification(s) is/ are done. Any change in NAME OF THE EQUIPMENT shall be executed through change control procedure as per SOP titled ‘Change Control’.

  • REFERENCES
    • User Requirement Specifications (Doc Number)
    • Design Qualification (Doc Number)
    • Installation Qualification (Doc Number).
    • Operational Qualification (Doc Number)

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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