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TEMPLATEFORPERFORMACEQUALIFICATIONPROTOCOL
Posted By: Pharmaceutical Guidanace on: March 27, 2016 In: Performance Qualication(PQ) No Comments
CONTENTS
1.0 Objective 3
2.0 Scope 3
3.0 Responsibility 3
6.0 Pre-requisites 4
12.0 Reference 5
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.
Head -Quality Assurance shall be responsible for approval of the Performance Qualication Report and certication after
PQ: Performance Qualication; documented verication that the integrated system or subsystem functions as intended, in its normal
operating environment.
participating in validation. For NAME OF THE EQUIPMENT, the validation team members shall enlist their names & signatures.
Equipment ID No.
Capacity
Location
PRE-REQUISITES
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.
During validation study the Data from each phase shall be compiled by Validation Team.
In case there is any deviation followed during any stage of validation, corrective action shall be taken after proper investigation. Deviations
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.
Approval Sheet
Qualication Reports
Certication of completion of validation
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
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