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Iq, Oq, PQ

This SOP describes the qualification process for an automatic filling machine, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The IQ confirms the machine was properly delivered and installed. The OQ tests the machine's operation and parameters. The PQ validates the machine's performance by filling and capping bottles at different quantities under real conditions.

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967 views3 pages

Iq, Oq, PQ

This SOP describes the qualification process for an automatic filling machine, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The IQ confirms the machine was properly delivered and installed. The OQ tests the machine's operation and parameters. The PQ validates the machine's performance by filling and capping bottles at different quantities under real conditions.

Uploaded by

chemist
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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GENITICS MEDITECH PVT LTD

Title : IQ, OQ and PQ for Automatic filling machine SOP No. GM SOP 021
Date : 19.04.2021 Rev No. : 1.0 Page 1 of 3
Rev Date : 19.04.2021

Prepared By: Prakash. V


Verified By: Soundhar. J

Revision History

History Revision No. Revised By Date


Initial draft 0.0 Prakash. V 18.04.2021
Final draft 1.0 Prakash. V 19.04.2021
GENITICS MEDITECH PVT LTD
Title : IQ, OQ and PQ for Automatic filling machine SOP No. GM SOP 021
Date : 19.04.2021 Rev No. : 1.0 Page 2 of 3
Rev Date : 19.04.2021

1.0 Purpose

The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for
Qualification of laboratory instrument/ equipment.

2.0 Scope

This SOP shall be used as such for Qualification of Laboratory Instrument / Equipment in
the Quality Control Department

3.0 Responsibility

 QC/QA Officers.

4.0 Procedure

4.1 Installation Qualification

 Automatic filling, bottling and capping machine is properly delivered without any
deviations.

 The machine was received along with the accessories.

 The machine is installed at the proper location, proper energy supply and acceptable
environmental conditions.

 Verified against the bills and contents, computer controlled information and
installation certificate.

4.2 Operational Qualification

 Automatic filling, bottling and capping machine is specified for Automatic bottling,
filling and capping of products related to solutions. Therefore, the machine Automatic
filling, bottling and capping machine is operating as per the requirement.

 The machine is tested for fluctuations and other parameters and no deviations was
observed occur during the operation.
GENITICS MEDITECH PVT LTD
Title : IQ, OQ and PQ for Automatic filling machine SOP No. GM SOP 021
Date : 19.04.2021 Rev No. : 1.0 Page 3 of 3
Rev Date : 19.04.2021

4.3 Performance Qualification

 Machine was operated with different qty of bottles to validate the proper filling and
capping.

 It was observed, that after changing the inputs of filling machine by manually, the
desired qty of solution is filled in the appropriate bottles.

 Therefore, the performance of the machine is effective as expected under real


conditions.

Prepared By Approved By

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