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Study For Medical Devices

The document discusses IQ, OQ, and PQ which are sequential validation activities manufacturers use to validate manufacturing processes for medical devices. IQ validates equipment installation, OQ validates equipment operation, and PQ validates long-term process stability and ability to consistently produce conforming products. The validation process establishes that equipment is installed correctly, operates as required, and the process safely produces products meeting requirements under normal operating conditions.

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eduardo dominguez
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221 views5 pages

Study For Medical Devices

The document discusses IQ, OQ, and PQ which are sequential validation activities manufacturers use to validate manufacturing processes for medical devices. IQ validates equipment installation, OQ validates equipment operation, and PQ validates long-term process stability and ability to consistently produce conforming products. The validation process establishes that equipment is installed correctly, operates as required, and the process safely produces products meeting requirements under normal operating conditions.

Uploaded by

eduardo dominguez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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What are IQ, OQ, and PQ?

IQ, OQ, and PQ are sequential activities that manufacturers carry out to validate
their manufacturing processes. IQ stands for Installation Qualification, OQ for
Operational Qualification, and PQ for Performance Qualification. The purpose of
process validation is to establish documented evidence that the production
equipment is correctly installed, operates according to requirements, and performs
safely. It is also to demonstrate that the manufacturing process under normal
operating conditions will consistently produce conforming products.

The ideal way to ensure the quality of medical


devices
In each phase of the validation process, documents are compiled with detailed
results of each qualification test. After performing IQ, OQ, and PQ successfully with
the desired result and established documents that verify each phase, a
manufacturing process can get underway. The defined discipline for a validation
process has proven to be the ideal way to guarantee the best quality of medical
devices consistently over time.

Which manufacturing processes must be validated?


Any medical device manufacturing processes where the result is not verifiable by
subsequent monitoring or measurement must be validated. A validation plan
should be established including the steps of IQ, OQ, and PQ for each process. The
approach should be risk-based to ensure critical parameters or specifications are
adequately taken care of.

IQ validates that equipment is correctly installed


IQ is the first step in the validation process. In this phase, you verify that the
manufacturing equipment meets the design specifications and has been correctly
installed and configured according to requirements. You need to confirm that all
necessary documents, drawings, and manuals are correctly executed and available.
During IQ, equipment maintenance as well as calibration schedules and procedures
should be established.

OQ validates that equipment operates as intended


OQ is the second step in the validation process. In this phase, you verify that the
manufacturing equipment operates according to requirements. You need to carry
out tests for each component to confirm that every part of the manufacturing
equipment operates as intended at pre-set thresholds. By challenging the
manufacturing process using “worst-case” conditions, it is possible to determine
your process window and to ensure a   reproducible manufacturing process
resulting in conforming products.

PQ validates process stability over time


PQ is the third and last step of the validation process. In this phase, you verify
process stability over time by running the equipment several times with a load
under normal operating conditions to challenge its functionality and safety. This will
demonstrate if the process will produce a product that conforms to its
requirements.

Why are IQ, OQ, and PQ so important in medical


device manufacturing?
Medical devices are intended to be used for humans and need to meet regulatory
requirements. IQ, OQ, and PQ are important steps in a validation process to prove
that the medical devices meet all predetermined requirements for functionality and
safety, as well as the regulatory standards. Non-conforming products could lead to
human injury and result in costly product recalls. A well-planned and performed
validation process is crucial for manufacturers to ensure that they have a controlled
manufacturing process that consistently produces conforming products that
ensure the quality and safety of the medical device.

How are IQ, OQ, and PQ carried out correctly?


IQ, OQ, and PQ should be carried out by the manufacturer according to
the FDA and ISO standards. Read more about these standards and the tasks
associated with IQ, OQ, and PQ validation in the links below. Also, the GHTF (Global
Harmonization Task Force) provides guidance that clarifies how to act. (The guide is
an internationally harmonized document recognized by both the FDA and ISO).

●  FDA Quality System Regulation (21 CRF Part 820)

●  ISO 13485: 2016 Medical Devices – Quality Management System


●  GHTF Quality Management Systems – Process Validation Guidance
(GHTF/SG3/N99-10:2004 Edition 2)
Understanding IQ, OQ and PQ for Medical Device
Manufacturing Processes
The goal is process validation is to produce a stable medical device manufacturing process that
offers consistent performance. Variation is minimal and predictable. Your Process Validation Plan
(PVP) will provide the framework for executing three important phases in the validation process.

Installation Qualification (IQ): Is everything installed correctly?


Operational Qualification (OQ): Is everything operating correctly? Are operating limits understood?
Performance Qualification (PQ): Did it produce the correct result? Is the process stable and capable?

What is Installation Qualification (IQ)?

IQ can be executed by the facilities, engineering, production or operations groups and the basic idea is
to ensure that everything is installed properly. During this qualification phase the installation of
equipment, piping, services, and instrumentation will be checked against engineering drawings, piping
and instrument diagrams (P&ID), and functional specifications developed during the project planning
stage. During the project planning stage, all system elements, service conduits, and gauges are
identified, and a documented record is prepared showing that all installed equipment satisfies your
requirements. At various stages during IQ, you will need to review, check, report, and authorize
protocols, documentation, procedures, equipment, specifications, and acceptance criteria for test
results.

IQ touches on many tangible and intangible aspects related to installation including:

 Components and equipment.

 Software and Standard Operating Procedures (SOP).

 Calibration and testing.

 Installation.

 Software and systems testing.

 Records.

 Electrical.

 Signals and alarms.

 Revalidation, facility conditions, documentation.

There should be an SOP, checklist or some other documented process that defines the standard
installation procedure for each type of system or deliverable being installed. This is required for any
equipment used in the manufacturing process. IQ verifies and documents key aspects of an installation
meet approved requirements. These requirements may come from:

 Design specifications.

 System specifications.

 Manufacturer’s recommendations.

 Developers’ recommendations.

 Data sheets.

With IQ Complete, It’s Time to Conduct the Medical Device OQ Process

After you have performed IQ and checked all aspects of installation, the next step is to perform
Operational Qualification (OQ). This is where you challenge your parameters to make sure your
process will result in a product that meets requirements. OQ is associated with equipment
performance to ensure that the functions of machines, measuring devices, utilities, and
manufacturing areas perform as intended throughout all anticipated operating ranges in the selected
environment. This is typically accomplished by identifying important process variables and providing
evidence that even if you produce devices at limits of those parameters they will still meet specs.
The OQ process does the following:

 Identifies the critical operating parameters


 Lists the experiments to be conducted on the critical variables
 Describes the sequence of the experiments
 Lists the necessary measuring equipment
 Ensures the acceptance criteria for the product can be met

It also includes the procedures required to verify specific dynamic attributes of the new or modified
process throughout its operating range, which may include worst-case conditions.

The Completion of OQ Leads to Performance Qualification (PQ)

With OQ successfully completed, you can move on to conduct PQ – the final stage in the validation
process. By now all the bugs should have been worked out during IQ and OQ so that the PQ should
(hopefully) proceed smoothly. During this phase you will generate evidence that your process will
consistently produce an acceptable product under normal operating conditions over the long-term. PQ
is performed on the manufacturing process as a whole. Components of the system or process are
typically not tested individually.

Performance Qualification should also include testing the system against its operational capacity but not
exceeding it. It is important at this stage to ensure that all operational test data conform with
predetermined acceptance criteria from the previous qualifications.

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