PERFORMANCE QUALIFICATION PROTOCOL
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VIBRO SIFTER
PERFORMANCE QUALIFICATION PROTOCOL
OF
VIBRO SIFTER
BLOCK : PDL
NAME OF THE EQUIPMENT : VIBRO SIFTER
MAKE : RAMASHARY PHARMA MACHINERY PVT. LTD.
MODEL / TYPE : GMP
EQUIPMENT I. D. : GB/P/001
SUPERSEDED PROTOCOL NO. : NIL
EFFECTIVE DATE :
Approved By
Head QA
Format No.: QA-030/F8-00
PERFORMANCE QUALIFICATION PROTOCOL
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TABLE OF CONTENTS
Sr. No. Content
1. Pre- Approval
2. Objective
3. Scope
4. Qualification team and Responsibilities
5. Methodology for performance qualification
6. Acceptance criteria
7. Conclusion
8. Performance verification of Equipment
9. Deficiency sheet
10. Abbreviation(s)
11. Attachment(s)
12. Summary and Conclusion
13. Post Approval
Approved By
Head QA
Format No.: QA-030/F8-00
PERFORMANCE QUALIFICATION PROTOCOL
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1.0 PROTOCOL APPROVAL:
Prepared By:
Functional Area Name Signature Date
Officer /Executive-
QA
Reviewed By:
Functional Area Name Signature Date
Head Production
Head Engineering
Manager-QA
Approved By:
Functional Area Name Signature Date
Head QA
Authorized By:
Functional Area Name Signature Date
Head Quality
Approved By
Head QA
Format No.: QA-030/F8-00
PERFORMANCE QUALIFICATION PROTOCOL
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2.0 Objective
The purpose of Performance qualification is to provide the documented evidence that the Vibro
sifter is performing as per the parameter defined in performance qualification and that gives result
that meet predetermined acceptance criteria.
3.0 Scope
This qualification protocol will be performed to the Vibro sifter .
This protocol defines the documentation, references & acceptance criteria to establish that
the Vibro sifter was operated in accordance with the supplier’s specifications and its
intended use.
4.0 Qualification Team & Responsibility
4.1 Quality Assurance:
Prepare and review the document ensuring that the content is sufficient, clearly defined and
technically accurate.
Execution and verification of performance qualification activity as per document.
4.2 Production:
Reviews the Performance qualification document.
Operates the equipment as per SOP and variables defined in the performance qualification
document.
4.3 Engineering:
Review the Performance qualification document.
Ensure the proper functioning of the equipment and measuring devices and provide technical
support during execution of document.
4.4 Head – QA
Review and approval of the Performance qualification document, the completed qualification
data and the compiled report.
Assist in the resolution of performance variances.
5.0 Methodology for Operation Qualification
5.1 The effectiveness of Vibro sifter will be qualified by determining particle size with the sieve.
Approved By
Head QA
Format No.: QA-030/F8-00
PERFORMANCE QUALIFICATION PROTOCOL
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5.2 Any three lots/batch of API & Dried granules of a product will be taken for performance qualification of
Sifter.
5.3 Particle size will be checked during performance qualification.
5.4 In case of any deviation inform to department head for necessary action.
5.5 Document the deviation details in Observed deviation section.
5.6 The Quality head and the department head will be decided whether deviation is acceptable or not.
5.7 If deviation is not acceptable inform to concern department head and Quality head for necessary action
6.0 Acceptance criteria
6.1 The particle size should not be greater then sieve micron size.
6.2 The equipment should work smoothly with minimum noise while operating
6.3 The equipment should produce intended outputs with respect to quality & quantity consistently.
7.0 Conclusion
7.1 The equipment shall be considered qualified for regular usage provided it should meet the acceptance
criteria of performance qualification.
7.2 The performance test reports shall be evaluated & equipment shall be released for Carrying out the
routine process.
Approved By
Head QA
Format No.: QA-030/F8-00
PERFORMANCE QUALIFICATION PROTOCOL
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8.0 Performance Verification of Equipment
PRODUCT DETAIL
Date :
Product :
Batch No. :
Qty. taken :
Reference sieve :
sieve analysis
Batch No. No. of Runs Pass through #30 Retained through #30
Remarks
ASTM sieve(kg) ASTM sieve(kg)
Run 1
Run 2
Performed Checked
Date Date
by by
Run 1
Run 2
Performed Checked
Date Date
by by
Run 1
Run 2
Performed Checked
Date Date
by by
Approved By
9.0 Deficiency sheet Head QA
Format No.: QA-030/F8-00
PERFORMANCE QUALIFICATION PROTOCOL
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10.0 Abbreviations
Abbreviation Full Form
RPM : Rotation per minute
HP : Horse power
KG : Kilogram
11.0 Attachment(S) Approved By
Head QA
Format No.: QA-030/F8-00
PERFORMANCE QUALIFICATION PROTOCOL
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SR. No. Details of Annexure Annexure No.
Approved By
Head QA
Format No.: QA-030/F8-00
PERFORMANCE QUALIFICATION PROTOCOL
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12.0 Summary and Conclusion
Approved By
Head QA
Format No.: QA-030/F8-00
PERFORMANCE QUALIFICATION PROTOCOL
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13.0 POST APPROVAL
Prepared By:
Functional Area Name Signature Date
Officer/Executive-QA
Reviewed By:
Functional Area Name Signature Date
Head Production
Head Engineering
QA
Approved By:
Functional Area Name Signature Date
Head QA
Authorized By:
Functional Area Name Signature Date
Head Quality
Approved By
Head QA
Format No.: QA-030/F8-00
