Merge&ConvertFiles

StartDownload intoPDFsw/
ViewPDF EasyPDFCombine
Free!

TEMPLATEFORPERFORMACEQUALIFICATIONPROTOCOL
Posted By: Pharmaceutical Guidanace on: March 27, 2016 In: Performance Qualication(PQ) No Comments

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 & Denitions 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 Qualication/ Validation Report Preparation 5

11.0 Re-validation/Re-qualication of Equipment 5

12.0 Reference 5

Protocol Preparation and Approval

Preparation and Checking:

Validation Team

Prepared by Checked by

 Quality Quality
Department Quality Control Production Production Quality Control
Assurance Assurance

Name

Signature

Date

Approval:

Approved by

Head-Production Head- Quality Control Head- Quality Assurance

Name

Signature

Date

OBJECTIVE

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

ensure the system reproducibility over an appropriate time period as per user requirement specications No.

Ensure that the system is showing consistency in producing Product of pre-established specications.

SCOPE

This procedure applies to the Performance Qualication 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 Qualication/Validation protocol.

Head-Production, Head-Quality Control & Head-Quality Assurance shall be responsible for the approval of Performance

Qualication 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 Qualication Report and certication after

successful qualication of Equipment.

ABBREVIATIONS AND DEFINITIONS

PQ: Performance Qualication; documented verication that the integrated system or subsystem functions as intended, in its normal

operating environment.

DQ: Design Qualication.

IQ: Installation Qualication.

OQ: Operational Qualication

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 Qualication 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 rst 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 Qualication 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

Qualication Reports

Certication of completion of validation

RE-VALIDATION/ RE-QUALIFICATION CRITERIA

After completion of Performance qualication study, frequency of re-qualication or re-validation of NAME OF THE EQUIPMENT shall be xed.

Moreover the NAME OF THE EQUIPMENT shall invite revalidation as and when any major modication(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 Specications (Doc Number)

Design Qualication (Doc Number)

Installation Qualication (Doc Number).

Operational Qualication (Doc Number)

StartDownloadGetPDF
GetPDFConvert.coandconvertdocumentstoPDF.It'sFree!pdf
convert.co/free

StartDownloadGetPDF
GetPDFConvert.coandconvertdocumentstoPDF.It'sFree!pdf
convert.co/free

FreeDownload
ConvertWordToPDFwithFileConvertor.fileconvertor.org