Operational Qualification Protocol Cum Report FOR Paste Kettle

PURE & CURE OPERATIONAL QUALIFICATION
HEALTHCARE PVT. PROTOCOL CUM REPORT PROTOCOL No.:

LTD., HARIDWAR FOR PAK/OQ/GB/0008-00
PASTE KETTLE EFFECTIVE DATE:
30/12/15
PAGE No.: 1 of 19
OPERATIONAL QUALIFICATION
PROTOCOL CUM REPORT
FOR
PASTE KETTLE
EQUIPMENT ID. No. PC/GB/PAK-008

LOCATION Granulation -08 ‘G’ Block
FORMAT No.: CQA-003/F03-02

30/12/15
PAGE No.: 2 of 19
DATE OF QUALIFICATION
SUPERSEDE PROTOCOL No. NIL
PROTOCOL CONTENTS
S. No. TITLE PAGE No.

1.0
Protocol Pre-Approval 3
2.0 Objective 4
3.0 Scope 4
4.0 Responsibility 5
5.0 Equipment Details 6
6.0 System Description 6
7.0 Pre-Qualification Requirements 7
8.0 Critical Variables to be Met 8-13
9.0 References 14
10.0 Documents to be Attached 14
11.0 Deviation from Pre-Defined Specification, If Any 14
12.0 Change Control, If Any 14
13.0 Review (Inclusive of follow up action, If Any) 15
14.0 Conclusion 15
15.0 Recommendation 15
16.0 Abbreviations 16
17.0 Protocol Post Approval 17

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1.0 PROTOCOL PRE-APPROVAL:
INITIATED BY:
DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:

HEAD
(PRODUCTION)
HEAD
(ENGINEERING)
APPROVED BY:

HEAD
(QUALITY ASSURANCE)

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2.0 OBJECTIVE:
 To verify that the equipment operates in accordance with the design and user requirements as
defined by set Acceptance Criteria and comply with cGMP Requirements.
 To demonstrate that the system will operate reproducibly and consistently within its operating range.
 To verify the operational features of Paste kettle and to ensure that it produces desired Quality &
rated output according to manufactures specifications.
 To verify all the Operational features from user friendly point of view of the Machine, Cleaning
Procedure and Start up & Shut down Procedure and Safety Features.
3.0 SCOPE:
 The scope of this operational qualification protocol cum report is limited to qualification of Paste
kettle ( Make-Elicon , Capacity- 50 liter) installed in the Granulation- 08 of ‘G’ Block at Pure &
Cure Healthcare Pvt. Ltd., Haridwar.
 This Protocol will define the methods and documentation used to perform OQ activity the Paste
kettle for OQ. Successful completion of this Protocol will verify that Paste kettle meet all acceptance
criteria and ready for Performance Qualification.

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4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following departments,
shall be responsible for the overall compliance of this Protocol cum Report:
DEPARTMENTS RESPONSIBILITIES
Quality Assurance  Preparation, Review, Approval and Compilation of the Operational
Qualification Protocol cum Report.
 Co-ordination with Production and Engineering to carryout Installation
Qualification.
 Monitoring of Operational Qualification Activity.
 Post Approval of Operational Qualification Protocol cum Report after
Execution.
Production  Review & Pre Approval of Operational Qualification Protocol cum Report.
 To Co-ordinate and support for Execution of Qualification study as per
Protocol.
Execution.
Engineering  Review & Pre Approval of Operational Qualification Protocol cum Report.
 Co-ordination, Execution and technical support in Paste Kettle Installation
Qualification Activity.
 Calibration of Process Instruments.
 Responsible for Trouble Shooting (if occurs during execution).
Execution.

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5.0 EQUIPMENT DETAILS:

Equipment Name Paste Kettle
Equipment PC/GB/PAK-008
Manufacturer’s Name Elicon Pharma
S.NO EP/PCHPL/SPK-50-4/APR/2014
Model GMP Model
Supplier’s Name Elicon Pharma
Location of Installation Granulation -08, ‘G’ Block
6.0 SYSTEM DESCRIPTION:

Paste kettle is designed as per good manufacturing practice in terms of clean ability of components,
surface finish, absence of sharp corners, assembling and de-assembling of components and control
devices. Machine should be designed to be of jacketed type, electrically or steam heated, thermostatic
control with the unit, safety valve, insulated with suitable insulating 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.
MAIN FEATURES
 All contact part made of SS 316 as per GMP standard
 Hemispherical design for proper mixing of paste.
 Jacket provided with steam/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.

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7.0 PRE-QUALIFICATION REQUIREMENTS:

7.1 Verification of Documents:
 Executed and approved design qualification document.
 Executed and approved Installation qualification document.
 SOP For Operation & Cleaning of Paste Kettle
 SOP for Preventive Maintenance of Paste Kettle
7.1.1 Procedure:
 Verify the above mentioned documents for availability, completeness and approval status.
 If any deviation is observed the same has to be recorded giving reasons for deviation and approved.
Deviation should be approved by Authorized person.
 Approved Drawings and supporting documents would form a part of the OQ Protocol cum report.
7.1.2 Acceptance Criteria:

 All the documents should be available, complete and approved by respective authorities.
 The results of any tests should meet the limits and acceptance criteria specified in the test documents.
Any deviations or issues should be rectified and documented prior to OQ commencing.

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8.0 CRITICAL VARIABLES TO BE MET:

8.1 Documents Verification:
VERIFIED BY
CHECKED BY
S. COMPLETE Q.A
DOCUMENT DOCUMENT/SOP (ENGINEERING
NO D OFFICER/EXE
NAME NO. )
. (YES/NO) .
SIGN/DATE
SIGN/DATE
1. DQ Protocol Cum
Report
2. IQ Protocol Cum
Report
3. SOP for operating
& Cleaning of
Paste Kettle
4. SOP for Preventive
Maintenance of
Paste Kettle
Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

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Reviewed By
(Manager QA)
Sign/Date: ………………
8.2 Test Equipment Calibration:
Verify that all critical instruments associated with the system will be in a calibrated state. Review the
calibration status for the test equipment to be utilised and record the calibration due dates in the table
below. All Equipment/Instrumentation must remain within the calibration due date for the duration of
OQ test for which the item is used. If a due date potentially occurs during the testing period then the
instrument must be recalibrated before it can be utilised.
EQUIPMENT/ EQUIPMENT/ CALIBRATION DUE ON OBSERVED BY

INSTRUMENTS INSTRUMENT ON SIGN/DATE
NAME ID
Checked By Verified By
(Production) (Quality Assurance)
Sign/Date: …………………… Sign/Date: …………………
Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

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………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
Reviewed By
(Manager QA)
Sign/Date: ……………………
8.3 Operational and Functional Checks:
Operate the Paste Kettle as per Manufacturer’s Manual/SOP and Check for the following functions of
the Equipment. The Equipment should function as desired.
Objective:
To verify that all the components on the control panel of machine provides the proper functioning as
specified by the manufacturer.
Testing procedure:
1. Check all the components on the control panel are properly labeled /identified.
2. Turn ‘ON’ the power to the control panel.
3. Set the required “controls” on the panel
4. Verify the functioning of each key/component on the panel against its specified function.
5. Observe and record the response on each component on the panel.
Sign/Date: …………………… Sign/Date: ……………………
Inference:

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………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
Reviewed By
(Manager QA)
8.4 Safety Testing/Interlocking:
OBSERVED BY
DESCRIPTION OF FUNCTIONING AS (ENGINEERING
DEVIATION
“SAFETY FEATURE” SPECIFIED (YES/NO) )
SIGN/DATE
Main switch
Temperature gauge
M.C.B for electrical

overload
Machine overload
mechanism

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Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
Reviewed By
(Manager QA)
Sign/Date: …………………
8.5 Power Failure Verification:
OBSERVED BY
ITEM ACCEPTANCE CRITERIA OBSERVATION (ENGINEERING)
SIGN/DATE
Main Power shut Equipment stops in safe and
down secure condition
Main Power Restored Equipment can be restarted

with no problems or adverse
conditions.
Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………

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Reviewed By
(Manager QA)
8.6 Emergency Operation Verification:
OBSERVED BY
ACCEPTANCE
ITEM OBSERVATION (ENGINEERING)
CRITERIA
SIGN/DATE
Emergency Stop: Equipment should
 Press Emergency Stop
Stop Push Button
 Release Emergency
Stop Push Button Equipment should
Start
With the Emergency Stop The Equipment will
Pressed in, try to cause be inoperative
Movement of an
Operating function
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Inference:
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
Reviewed By
(Manager QA)
9.0 REFERENCES:
The Principle Reference is the following:
 Validation Master Plan

 Schedule-M – “Good Manufacturing Practices and Requirements of Premises, Plant and
 Equipment for Pharmaceutical Products.
 WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol-2 – Good Manufacturing
Practices and Inspection.
10.0 DOCUMENTS TO BE ATTACHED:

 Operation And Maintenance Manual
 Calibration Certificate of Test Instrument.
11.0 DEVIATION FROM PREDEFINED SPECIFICATION, IF ANY:

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………

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………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
12.0 CHANGE CONTROL, IF ANY:

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
13.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY ):

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
14.0 CONCLUSION:
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
15.0 RECOMMENDATION:
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………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
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………………………………………………………………………………………………………………
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………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
16.0 ABBREVIATIONS:
cGMP : Current Good Manufacturing Practices
CQA : Corporate Quality Assurance
DQ : Design Qualification
HP : Horse Power
ID. : Identification
IQ : Installation Qualification
Ltrs : Liters
MCB : Miniature Circuit Breaker
MOC : Material of Construction
NLT : Not Less Than
No. : Number
OQ : Operational Qualification
PAK : Paste Kettle
PC : Pure & Cure
PLC : Programmable logical Control
QA : Quality Assurance
SS : Stainless Steel
WHO : World Health Organization
GB : General Block

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17.0 PROTOCOL POST -APPROVAL:
INITIATED BY:
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:

HEAD
(PRODUCTION)
HEAD
(ENGINEERING)

30/12/15
PAGE No.: 19 of 19
APPROVED BY:
HEAD
(QUALITY ASSURANCE)

Operational Qualification Protocol Cum Report FOR Paste Kettle

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PURE & CURE OPERATIONAL QUALIFICATION

HEALTHCARE PVT. PROTOCOL CUM REPORT PROTOCOL No.:

PROTOCOL CUM REPORT

EQUIPMENT ID. No. PC/GB/PAK-008

FORMAT No.: CQA-003/F03-02

S. No. TITLE PAGE No.

5.0 Equipment Details 6

6.0 System Description 6

7.0 Pre-Qualification Requirements 7

8.0 Critical Variables to be Met 8-13

10.0 Documents to be Attached 14

11.0 Deviation from Pre-Defined Specification, If Any 14

12.0 Change Control, If Any 14

13.0 Review (Inclusive of follow up action, If Any) 15

17.0 Protocol Post Approval 17

FORMAT No.: CQA-003/F03-02

FORMAT No.: CQA-003/F03-02

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

FORMAT No.: CQA-003/F03-02

FORMAT No.: CQA-003/F03-02

FORMAT No.: CQA-003/F03-02

5.0 EQUIPMENT DETAILS:

6.0 SYSTEM DESCRIPTION:

FORMAT No.: CQA-003/F03-02

7.0 PRE-QUALIFICATION REQUIREMENTS:

7.1.2 Acceptance Criteria:

FORMAT No.: CQA-003/F03-02

8.0 CRITICAL VARIABLES TO BE MET:

FORMAT No.: CQA-003/F03-02

8.2 Test Equipment Calibration:

EQUIPMENT/ EQUIPMENT/ CALIBRATION DUE ON OBSERVED BY

FORMAT No.: CQA-003/F03-02

8.3 Operational and Functional Checks:

FORMAT No.: CQA-003/F03-02

8.4 Safety Testing/Interlocking:

M.C.B for electrical

FORMAT No.: CQA-003/F03-02

8.5 Power Failure Verification:

Main Power Restored Equipment can be restarted

FORMAT No.: CQA-003/F03-02

8.6 Emergency Operation Verification:

 Validation Master Plan

10.0 DOCUMENTS TO BE ATTACHED:

11.0 DEVIATION FROM PREDEFINED SPECIFICATION, IF ANY:

FORMAT No.: CQA-003/F03-02

12.0 CHANGE CONTROL, IF ANY:

13.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY ):

FORMAT No.: CQA-003/F03-02

17.0 PROTOCOL POST -APPROVAL:

DESIGNATION NAME SIGNATURE DATE

FORMAT No.: CQA-003/F03-02

DESIGNATION NAME SIGNATURE DATE

FORMAT No.: CQA-003/F03-02

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