HELIX PHARMA (PRIVATE) LIMITED

VALIDATION PROTOCOL
Document # VP/PRD/EQP-PQ-045
TITLE: Issue # 01
Effective Date 12-05-2020
PERFORMANCE QUALIFICATION OF AIR SHOWER Review Date 12-05-2024
Supersede # 00
Page 1 of 4
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 Performance qualification specification 3
6.0 Summary and conclusion 3
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-PQ-045
TITLE: Issue # 01
Effective Date 12-05-2020
PERFORMANCE QUALIFICATION OF AIR SHOWER Review Date 12-05-2024
Supersede # 00
Page 2 of 4
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 Air
shower.

2.0 SCOPE:
This performance qualification protocol is applicable to air shower 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:

Air shower is a fully self-contained unit. They are fully equipped to provide complete de-
contamination solutions to the clean room or manufacturing/assembly area from
personnel entering the space.
Three Air showers has been purchased and their details are mentioned below:

Item Item Quantit PO No. Vendor Manufacturer

code Name y
FA-PMC- Air shower 03 13300581 Technocratic Shanzhen Xiangnan
0152 services High-Tech Purify
Equipment Co, Ltd.
Hong Kong.
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-PQ-045
TITLE: Issue # 01
Effective Date 12-05-2020
PERFORMANCE QUALIFICATION OF AIR SHOWER Review Date 12-05-2024
Supersede # 00
Page 3 of 4
PREPARED BY: APPROVED BY:

REVIEWED BY:

A.M. QA Director Regulatory

Affairs & QA

_______________ _____________ _________________

Production Manager Senior Manager QA GM Engineering GM Quality Operation
 HELIX PHARMA (PRIVATE) LIMITED
VALIDATION PROTOCOL
Document # VP/PRD/EQP-PQ-045
TITLE: Issue # 01
Effective Date 12-05-2020
PERFORMANCE QUALIFICATION OF AIR SHOWER Review Date 12-05-2024
Supersede # 00
Page 4 of 4
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 Air shower has been performed by Third party vendor
“TBM Associate”. The PQ report demonstrates that equipment has been/ has not been
qualified successfully and correctly.