Kreation Handicraft

Operational Qualification
Equipment
Page Number 1 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/OQ/001 00
Number Number
Equipment ID IA

Prepared by
Name/ Designation Signature Date

Vikal Sharma/Manager Quality Assurance

Remark:

Approved by (Validation Team)

Name Department Signature Date

 Kreation Handicraft
Operational Qualification
Equipment
Page Number 2 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/OQ/001 00
Number Number
Equipment ID IA

Table of Contents

SERIAL TITLE
NUMBER

1.0 Objective

2.0 Scope

3.0 Responsibility

4.0 Equipment Description

5.0 General verification (Annexures)

6.0 Functional verification (Annexures)

7.0 Deviations and OOS if any

8.0 Reference

9.0 Attachments

10.0 Summary

11.0 Conclusion
 Kreation Handicraft
Operational Qualification
Equipment
Page Number 3 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/OQ/001 00
Number Number
Equipment ID IA

1.0 Objective

The Objective of this protocol is to define the criteria for Operational Qualification of Pouch
Filling and sealing Machine. This protocol ensures the documented evidence that the Pouch
filling and sealing machine is designed as per required specification / Functional Specification
and equipment meets the current Good manufacturing practice (cGMP) requirements.

2.0 Scope

This protocol will define the test procedures, documentation references and acceptance
criteria, which will establish Pouch filling machine is designed according to the requirements of
Kreation Handicraft, Dehradun.

3.0 Responsibility
Preparation of this protocol-Maintenance department/Production/Quality Assurance

Review & execution of this protocol-QA, Engineering, Safety & Technical

Assembling all DQ data-Maintenance department/Production/Quality Assurance

Approval-Quality Assurance
Supplier-Nidan Packaging

4.0 Equipment Description:

Equipment Make / Model Equipment I.D. Working Capacity

Name Number
Pouch filling & Nidan Packaging / 60-65 stroke/minutes
IA
Sealing Modle-NP-800L
Machine

The Equipment is named as Pouch Filling and sealing machine- NP800 L which is used to pack liquid or
semi liquid. The system is consisting of a hopper for filling of liquid or semi liquid and it is made up SS
316.It is equipped with Top lid. The speed of the machine is up to approximately 65 strokes per minutes.
Operate the equipment as per manual.
 Kreation Handicraft
Operational Qualification
Equipment
Page Number 4 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/OQ/001 00
Number Number
Equipment ID IA

5.0 General Verification

5.1 Instrument Calibration

Identify and classify the measuring instruments as critical/non critical and calibrate as per the
procedure. Record the details in General Verification Sheet - Annexure- IX (9)
6.0 Functional Verification

Verification of test functions specific to the equipment/ system shall be carried out as per the
procedures mentioned in the protocol.

6.1 Control Panel Testing :

Check the electrical / pneumatic switches function testing provided on the control panel and
record the results in the General Verification Sheet - Annexure- X ( 10 )

6.2 Safety Features Testing:

Check all the safety features (interlocks) in connection with the equipment/system and record the
results in the General Verification Sheet - Annexure- XI ( 11)

6.3 Operational Testing

Verify the operating parameters of the equipment/instrument/system for the efficiency of the
equipment and its components.

7.0 Deviation & Out of Specification(s) if any:

__________________________________________________________________________________________

8.0 References) if any:

_____________________________________________________________________________________________

____________________________________________________________________________________________

9.0 Attachments

9.1 LIST OF GENERAL VERIFICATION FORMATS USED:

 Kreation Handicraft
Operational Qualification
Equipment
Page Number 5 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/OQ/001 00
Number Number
Equipment ID IA

Format Number Number of Summary Verified by /

copies (Complies / Does not date
comply)

9.2 List of Certificates:

Attachment Details
Number

10.0 Summary:

___________________________________________________________________________________________

___________________________________________________________________________________________

11.0 Conclusion:

The Pouch Filling and sealing machine (IA) has been tested and verified for Operational
Qualification as per the Protocol.

The equipment stands Qualified / Disqualified as per the observations made therein.

Hence it is concluded that equipment stands Qualifed / Not Qualified for Performance
Qualification.