Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

PERFORMANCE QUALIFICATION

PROTOCOL

FOR

DUST EXTRACTOR MACHINE

EQUIPMENT ID:

Revision Date Reason for revision

00 New Protocol has been prepared for Performance Qualification

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Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

Contents

Sr. No. Title Page No.

1.0 Approval 03
2.0 Objective 04
3.0 Scope 04
4.0 Responsibility 05
5.0 Training Attendance Sheet 06
6.0 System description 07
7.0 Reason for Qualification 08
8.0 08
Frequency of Qualification
9.0 Pre-qualification requirements 09
10.0 Test and checks 10
11.0 Reference 11
12.0 Documents to be attached 11
13.0 Non compliance 11
14.0 Deviation from Pre- define specification if any 11
15.0 Change control, if any 11
16.0 Abbreviations 12

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 Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

1.0 Protocol Approval:

Signing of this Performance Qualification protocol of Dust Extractor Machine indicates an agreement with
the performance qualification approach of Dust Extractor Machine in Production Department of Pvt.
Ltd. If any modification to this becomes necessary an addendum shall be prepared and duly approved.

Prepared By:
Name and Functional area Signature Date

Quality Assurance

Reviewed By:

Name and Functional area Signature Date

Production Manager

QC Manager

Engineering Manager

Approved By:
Name and Functional area Signature Date

Quality Assurance

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 Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

2.0 Objective:

The purpose of carrying out Performance Qualification of Dust Extractor Machine is to establish
documented evidence that the system performance is in accordance with the predefined specifications.

3.0 Scope:

The document includes the Performance Qualification procedure of the following system:
Name of the equipment Dust Extractor Machine
Equipment identification number
Supplier Name and address

Facility General Formulation Facility

Floor Ground floor
Room name & number Compression Area,

This protocol should be generated to qualify the performance of the system. In case of further modification
or relocation, some part of the same protocol can be used or separate protocol or addendum can be
generated.

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Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

4.0 Responsibility:

Department Responsibility

 Preparation, Review, Approval and Compilation of the Performance

Qualification Document.
Quality Assurance  Co-ordination with Quality Control, Production and Engineering to
carryout Performance Qualification Protocol Activity.
 Monitoring of Performance Qualification Protocol Activity.

 Review of Protocol
Production
 To Co-ordination and support Performance Qualification Activity.

 Review of Protocol
Quality Control
 To Co-ordination and support Performance Qualification Activity.

 Review of Protocol
Engineering
 To Co-ordination and support Performance Qualification Activity.

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Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

5.0 Training Attendance Sheet:

Sr. Trainee Sign & Trainer Sign &

Employee Name Emp. Code Evaluation
No. Date Date

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Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

6.0 System Description:

Process Equipemnt Description: The purpose of Dust Extractor Machine is to collect dust from
Tableting etc. machine.
Complete machine can be divided in following sub sections.
 Main (material contact portion)
 Machine Base
6.1 Technical Specification
6.1.1 Duct Collection Box
 MOC - SS316
 Inner Surface - Mirror polish
 Outer surface - Mirror polish
6.1.2 Duct Collection Nozzle
 MOC - SS316
 Inner Surface - Mirror polish
 Outer surface - Mirror polish
6.1.3 Body Cover
 MOC - SS316
 Inner Surface - Mirror polish
 Outer surface - Mirror polish
6.1.4 Electric Motor
 Power - 1 HP
 RPM - 2850
 Volt - 415, 3 Ph, AC

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Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

7.0 Reason for Qualification:

 New equipment in Compression Room
 After completion of the Successful Operational Qualification of the Equipment, it is imperative to
perform the performance qualification. The study will establish that the parameters area followed, critical
variable are under control and the quality of the output is, as desired.

8.0 Frequency of Qualification:

 Once in every Five Year.
 After any major breakdown or after major modification.

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Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

9.0 Pre Qualification Requirements:

The results of any test should meet the limits and acceptance criteria specified in the test documents. Any
deviations or issues should be rectified and documented prior to PQ commencing.

9.1 System pre-requisites:

 Verify the DQ/IQ and OQ of the Dust Extractor Machine has been executed and approved.
 Verify that the Operating and Cleaning SOP of the Dust Extractor Machine has been prepared.

Checked by Verified By
Sr. Completed
(Engineering ) (QA)
Descriptions of pre-requisites (Yes/No)
No. Sign & Date Sign & Date

Verify that the DQ / IQ and OQ of the Dust

Extractor Machine has been executed and
approved.
1. DQ Document No.:

2. IQ Document No.:

3. OQ Document No.:

4. SOP for Cleaning and Operation of Dust

Extractor Machine.
5. SOP for Preventive Maintenance of Dust
Extractor Machine.

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Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

10.0 Tests and Checks:

10.1 Performance Evaluation Using Drug Product:
 To verify the performance of equipment in the range of operational parameters established in Operational
Qualification Activity.
 To establish the performance based range of operating parameters for performance Qualification activity
using drug product.

10.2 Procedure:
 The Qualification study shall be carried out on 03 batches of same or different products.
 Start the Dust Extractor Unit.
 Start the compression machine of the batch which results in dust generation.
 Stop the dust extractor machine and compression machine.
 Immediately hold a black colored paper below the suction point.
 Check for any traces of powder falling down from the suction end point on the black paper.

10.3 Acceptance Criteria:

 No visible powder dust should be seen at the point of use or on the black color paper held below it.

10.4 Checklist of all Tests & Checks:

A checklist shall be provided to ensure that all tests or checks required for this protocol have been
executed. After execution observations shall be recorded in Performance Qualification Report.
 Verification of DQ, ID, OQ and other documents.
 Verification of Performance using Drug Products.

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Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

11.0 Reference:
 Validation Master Plan
 Schedule-M- “Good Manufacturing Practices and Requirements of Premises, Plant Equipment for
Pharmaceutical Products”.
 WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol-2 Good Manufacturing
Practices and Inspection.

12.0 Documents to be attached :

 Any other Relevant Documents.
 Calibration Certificate.
 Operation and Maintenance Manual.

13.0 Non Compliance:

 In case of any deviation observed during PQ, inform to Head QA for necessary action.
 Document the deviation detail in observed deviation section.
 The Head QA shall study the impact of deviation. If deviation is acceptable and it does not have an
impact on operation as well as on performance of the machine, prepare final conclusion.

14.0 Deviation from Pre- define specification if any:

 All deviations, non conformance and out of specification results obtained shall be investigated in
accordance with corresponding SOPs and documented in the qualification report.

15.0 Change Control, If any:

 Details of change control initiated during qualification activity shall be documented in the qualification
report.

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Document Name: Performance Qualification Protocol for Dust Extractor Machine

Identification Number: Document Number:

Effective Date: Revision No.:

16.0 Abbreviation:
WHO : World Health Organization
cGMP : Current Good Manufacturing Practices
PQ : Performance Qualification
OQ : Operational Qualification
GMP : Good Manufacturing Practices
QA : Quality Assurance

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