Document Name: Performance Qualification Protocol for Starch Paste Kettle (100 Liter)

Identification Number: Document Number:

Effective Date: Revision No.:

PERFORMANCE QUALIFICATION

PROTOCOL

FOR

STARCH PASTE KETTLE (100 LITER)

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 Starch Paste Kettle (100 Liter)

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 06
Training Attendance Sheet
6.0 System description 07
7.0 Reason for Qualification 07
8.0 07
Frequency of Qualification
9.0 Pre-qualification requirements 08
10.0 Test and checks 09
11.0 Checklist of all Tests & Checks 10
12.0 Reference 10
13.0 Documents to be attached 10
14.0 Non compliance 10
15.0 Deviation from Pre- define specification if any 11
16.0 Change control, if any 11
17.0 Abbreviations 11

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Document Name: Performance Qualification Protocol for Starch Paste Kettle (100 Liter)

Identification Number: Document Number:

Effective Date: Revision No.:

1.0 Protocol Approval:

Signing of this Performance Qualification protocol of Starch Paste Kettle (100 Liter)indicates an agreement
with the performance qualification approach of Starch Paste Kettle (100 Liter) 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 Starch Paste Kettle (100 Liter)

Identification Number: Document Number:

Effective Date: Revision No.:

2.0 Objective:

The purpose of carrying out Performance Qualification of Fluid Starch Paste Kettle (100 Liter) 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 Starch Paste Kettle (100 Liter)

Equipment identification number
Supplier Name and address
Facility General Formulation Facility
Floor Ground floor
Room name & number Granulation-I

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 Starch Paste Kettle (100 Liter)

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 Starch Paste Kettle (100 Liter)

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 Starch Paste Kettle (100 Liter)

Identification Number: Document Number:

Effective Date: Revision No.:

6.0 System Description:

Paste kettle is designed as per good manufacturing practices in terms of clean ability of components,
surface finish, and absence of sharp corners, assembling and de-assembling of components and control
devices. Machine should be designed to be of jackets type, electrically heated, thermostatic control with
the unit, safety valve, insulated with suitable insulting material, tilting with hand wheel. Easy transfer of
paste while tilting, unit should be provided with suitable lid to discharge. Bottom valve for steam water,
which should be easily removable and easily cleanable.
6.1 Main Feature:
 All contact part made of SS 316 as per GMP standard.
 Hemispherical design for proper mixing of paste
 Jacket provided with Electrical heating arrangement
 Tilting arrangement for kettle is provided for discharge for starch paste
 Anchor type impeller design for proper mixing of paste.
 Safe earthing system

7.0 Reason for Qualification:

 New equipment in Granulation
 After completion of the successfully Operation 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.
 After change of location.

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Document Name: Performance Qualification Protocol for Starch Paste Kettle (100 Liter)

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 Starch Paste Kettle has been executed and approved.
 Verify that the Operating and Cleaning SOP of the Starch Paste Kettle 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 Starch

Paste Kettle 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 Starch

Paste Kettle (100 Liter) GMP Model.
5. SOP for Preventive Maintenance of Starch
Paste Kettle (100 Liter) GMP Model.

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Document Name: Performance Qualification Protocol for Starch Paste Kettle (100 Liter)

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 three batches or Lots of same or different products.
 Take the required quantity of purified water as mentioned in the BMR and transfer to paste kettle.
 Heat the Purified Water to reach the required temperature
 Add starch slurry to paste following as per mentioned in the BMR
 Perform mixing and other activities mentioned for the process.
 Record the total time required to complete the process.
10.3 Acceptance Criteria:
 Heating should be sufficient to raise the temperature of the entire content of vessel and no agglomerate of
poorly cooked starch lump should appear in any location of the entire vessel.
 Discoloration of formed paste due to local overheating should not be found on any location of entire
vessel.
 Paste of all locations should have uniform consistency.
 Required time to achieve the temperature should be acceptable with respect to the quantity of formed
paste.

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Document Name: Performance Qualification Protocol for Starch Paste Kettle (100 Liter)

Identification Number: Document Number:

Effective Date: Revision No.:

11.0 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
 Qualification of paste kettle for paste preparation Efficiency.
 Qualification of jacketed Vessel for Heating Efficiency.

12.0 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.

13.0 Documents to be attached :

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

14.0 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.

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Document Name: Performance Qualification Protocol for Starch Paste Kettle (100 Liter)

Identification Number: Document Number:

Effective Date: Revision No.:

15.0 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.

16.0 Change Control, If any:

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

17.0 Abbreviation:
WHO : World Health Organization
cGMP : Current Good Manufacturing Practices
PQ : Performance Qualification
RMG : Rapid Mixture Granulator
GMP : Good Manufacturing Practices
QA : Quality Assurance

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