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Helix Pharma (Private) Limited: Validation Protocol

This validation protocol outlines the performance qualification of pass boxes used at Helix Pharma Private Limited. It details the objectives, scope, responsibilities, equipment, and specifications for qualification. Four pass boxes of different sizes will be qualified. The performance qualification will include functional testing of the HEPA filter integrity. Upon completion, a conclusion will verify if the pass boxes have successfully qualified or not based on the performance qualification report from the third party vendor.

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ziauddin bukhari
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238 views3 pages

Helix Pharma (Private) Limited: Validation Protocol

This validation protocol outlines the performance qualification of pass boxes used at Helix Pharma Private Limited. It details the objectives, scope, responsibilities, equipment, and specifications for qualification. Four pass boxes of different sizes will be qualified. The performance qualification will include functional testing of the HEPA filter integrity. Upon completion, a conclusion will verify if the pass boxes have successfully qualified or not based on the performance qualification report from the third party vendor.

Uploaded by

ziauddin bukhari
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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HELIX PHARMA (PRIVATE) LIMITED

VALIDATION PROTOCOL
Document # VP/PRD/EQP-PQ-046
TITLE: Issue # 01
Effective Date 12-05-2020
PERFORMANCE QUALIFICATION OF PASS BOX Review Date 12-05-2024
Supersede # 00
Page 1 of 3
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory


Affairs & QA

________________ _____________ _________________


Production Manager Senior Manager QA GM Engineering GM Quality Operation

TABLE OF CONTENTS
Sectio
Description Page No.
n
1.0 Objectives 2
2.0 Scope 2
3.0 Responsibilities 2
4.0 Equipment details 2
5.0 Operation qualification specification 3
6.0 Summary and conclusion 3
HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-PQ-046
TITLE: Issue # 01
Effective Date 12-05-2020
PERFORMANCE QUALIFICATION OF PASS BOX Review Date 12-05-2024
Supersede # 00
Page 2 of 3
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory


Affairs & QA

________________ _____________ _________________


Production Manager Senior Manager QA GM Engineering GM Quality Operation

1.0 OBJECTIVE:
Purpose of performance qualification is to ensure and qualify the performance of pass
box.

2.0 SCOPE:
This performance qualification protocol is applicable to pass boxes in sterile area.

3.0 RESPONSIBLITIES:
3.1 QA responsible for generating the PQ protocol.
3.2 QA, QC, Production, Engineering are responsible for reviewing the protocol.
3.3 Director RA & QA responsible for approval of protocol.

4.0 EQUIPMENT DETAILS:


Dynamic Pass box is designed to obtain cleanliness level complies with Class 100/ISO-5
at rest condition and ability to sweep away contaminants generated during handling and
to maintain the required classified conditions.
Four Pass boxes have been purchased and their details are mentioned below:
Item Item Name Quantit PO No. Vendor Manufacturer
code y
FA-FFX- Pass box 02 13300580 Technocratic N/A
0255 (36”x24”36”) services
FA-FFX- Pass box 02 13300580 Technocratic N/A
0254 (42.5”x38.5”x78” services
)
HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-PQ-046
TITLE: Issue # 01
Effective Date 12-05-2020
PERFORMANCE QUALIFICATION OF PASS BOX Review Date 12-05-2024
Supersede # 00
Page 3 of 3
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory


Affairs & QA

________________ _____________ _________________


Production Manager Senior Manager QA GM Engineering GM Quality Operation

5.0 PERFORMANCE QUALIFICATION SPECIFICATION


5.1 Functional test for performance: HEPA filter integrity test
Objective
Pre-requisites
Procedure
Test results
Acceptance criteria
Deviation

Checked by: Name: Sign:

Designation: Date:

Verified by: Name: Sign:

Designation: Date:

6.0 CONCLUSION AND SUMMARY


The performance qualification of Pass box has been performed by Third party vendor
“TBM Associate”. The PQ report demonstrates that equipment has been/ has not been
qualified successfully and correctly.

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