IQ, OQ, PQ - A Guide to Process Validation
Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical devices.
· Installation
Qualification (IQ) - Installation qualification is used to ensure that the
installation of any necessary equipment, piping, services, or instrumentation
has been executed in accordance with the manufacturer's requirements.
· Operational
Qualification (OQ) - During operational qualification, the equipment should be
tested to determine process control limits, potential failure modes, action
levels, and worst-case scenarios.
· Performance
Qualification (PQ) - In the performance qualification phase, the goal is to demonstrate
that the process will consistently produce acceptable results under normal
operating conditions.
When do
you use IQ, OQ and PQ?
Asked below
mentioned questions to get the answer.
IQ – Is
everything installed correctly?
OQ – Is
everything operating correctly? & What are the operating limitations of the
device?
PQ – Does
this process produces the right results? & Is the process safe and
consistent?
IZiel
provides complete expertise in process validation and assists medical device manufacturers
to consistently meet required parameters through their optimized manufacturing
process.
IZiel’s
Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4
engineers from our Technical Center in India. Typically, the data is collected,
evaluated and evidence is developed from the process design stage throughout
production. Our Model enables the company to complete the project faster and in
a cost-effective manner.
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