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9/3/2020 PERFORMANCE QUALIFICATION PROTOCOL

PERFORMANCE QUALIFICATION PROTOCOL


 Pharmaceutical Guidanace  April 13, 2018  Performance Qualification(PQ), Validation & Qualification
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PERFORMANCE QUALIFICATION PROTOCOL

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TABLE OF CONTENTS

1.0 PROTOCOL APPROVAL

2.0 OBJECTIVE

3.0 SCOPE

4.0 RESPONSIBILITY

5.0 ACCOUNTABILITY

6.0 METHOD

7.0 RECORDING

8.0 ABBREVIATIONS

9.0 REFERENCES.

10.0 REVISION OF PROTOCOL

1.0 PROTOCOL APPROVAL:

Protocol Prepared by:

QA is responsible for the preparation of protocol for Performance Qualification of Nitrogen plant.

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NAME DESIGNATION SIGNATURE DATE

Protocol Checked by:

Validation Core Committee Member responsible to review the Protocol for performance qualification of

Nitrogen plant located in Utility section.

NAME DESIGNATION SIGNATURE DATE

Protocol Approved by:

DGM – Tech is responsible to approve the performance qualification protocol.

NAME DESIGNATION SIGNATURE DATE

2.0 OBJECTIVE
The objective of this protocol is to establish sufficient data to assure that the Nitrogen plant is suitable for the

production of nitrogen gas qualifies for the performance qualification used in various processes of
production department. Validation of the Nitrogen gas is carried out by monitoring the Microbial Quality of

Nitrogen gas from all the User Points.

Performance Qualification Protocol shall provide the Methodology of qualification studies, Criteria of

Qualification procedure and a guideline for documentation of the study.

3.0 SCOPE
These procedures are to be performed after the installation and operational qualification have been

completed and approved.

These procedures are to be performed, as per the schedule given to assure that the system performance
is consistent between the period, after completion of performance qualification study and before

conducting a revalidation study.

These procedures are to be performed after any major modification of the equipment or relocation and for

revalidation during appropriate intervals.

Any change in user point location and pipe line.

To show that the Nitrogen Plant installed in the Utility section performs for its intended use. 
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4.0 RESPONSIBILITY
A plan to carry out the validation shall be prepared in the form of a protocol.

The validation team members shall be responsible to carry out the validation.

5.0 ACCOUNTABILITY
Head – Quality Assurance.

6.0 METHOD
VALIDATION TEAM MEMBERS :

S. No. Name Department

SYSTEM DESCRIPTION

Pure nitrogen is obtained by removing oxygen from air in two stages. Oil free compressed air is first

dehumidified (anhydrous alumina is the desiccant) and is passed through a 0.01 micron filter and then

column of Carbon Molecular Sieve (CMS) where oxygen is adsorbed from this column. Then it is further
purified by passing through a copper catalyst column where nitrogen of purity of 99.99 % is obtained. This

plant also has an oxygen analyzer which is connected to an automatic dumping system which operates
when the oxygen content is more than 2 ppm.

The Nitrogen is further filtered through 0.01 micron and is circulated to different user points through SS 316

L pipelines. Terminal additional 0.22 micron filter is given at all user points. All the user point lines are made

out of PU.

Validation of nitrogen gas system includes

Moisture content

Oil content.

Non viable particles count

Viable particles count

Potency

Dew Point

TEST PROGRAM AND ACCEPTANCE CRITERIA

MICROBIAL QUALITY 
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Monitor quality of Nitrogen gas from all the user points for three consecutive days. Microbial content by

bubbling Nitrogen gas from 0.22 micron final filter through 200 ml of filtered highly purified water. Then that
water is handover to microbiology department for sterility testing.

Acceptance Criteria:

At the end of 14 days incubation, the media shall show no growth of organisms in the Broth for all the three
runs.

PARTICLE COUNT TESTING:

Monitor the quality of Nitrogen gas from all the user points for three consecutive days, particulate content by
bubbling the Nitrogen gas from 0.22 micron filter in 0.22 micron filtered WFI for 5 minutes. Testing the
bubbled water for particulate matter by liquid particle counter.

Acceptance Criteria:

For all the user points: 10 micron size should not more than 6000 particles,20 micron size should not

more than 600 particles.

MOITURE AND OIL CONTENT:

Check the chemical quality (presence of Moiture and Oil content) of the Nitrogen gas from plant out let and
other user points by blowing the Nitrogen gas on to a Blotting paper.

Acceptance Criteria:

Nitrogen gas from Plant Out let and other user points shall not have moisture and oil present in it.

REVALIDATION CRITERIA

System should be revalidated under following conditions

Major changes have been done to the system

Every year

7.0 RECORDING: 
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After completion of each study, a report shall be prepared by the validation team members which shall
include the following information.

Tabulated Data.

Validation Team Members and their Signatures.

Summary Report

Evolution of results

Quality Assurance Department Certification.

8.0 ABBREVIATIONS:

WFI → Water For Injection

NMT → Not More Than.

NLT → Not Less Than.

GTP → General Test Procedure

9.0 REFERENCES
Nil.

10.0 REVISION OF PROTOCOL:


New Protocol

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