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EQUIPMENT QUALIFICATION

Neutron IQ/OQ documentation was founded on the following documentation tree, starting with the first module, the Master Document (MD), followed by the Installation Qualification (IQ) and finally the Operational Qualification (OQ).

The OQ is then sub-divided into individual component tests (Hardware and Software) and a holistic test to verify the complete system.

ANALYTICAL INSTRUMENT QUALIFICATION (AIQ)

Neutron can provide expert advice on this matter.

Neutron IQ/OQ documentation was founded on the following documentation tree, starting with the first module, the Master Document (MD), followed by the Installation Qualification (IQ) and finally the Operational Qualification (OQ).

Master Document (MD)

The Master Document (MD) is the start and central organizing document for the AIQ procedures of each qualification. It not only details the installation process and qualification of the instruments but also the education level and competence of the qualifying engineer.

The MD determines all other components to tally up to the qualification, leading to a flexible framework on which to develop a set of documentation.

Installation Qualification (IQ)

One definition of the documentation content is complete in the MD, the Installation Qualification (IQ) follows. This set of documentation was developed to ensure adequate delivery and installation of the instrument and any accessories have been completed.

Additionally, the IQ protocol details that the workplace is appropriate for the analytical system as stipulated.

Operational Qualification (OQ)

The main part of the qualification comes after proper installation has been completed: the Operational Qualification (OQ). In the first part of the OQ, testing and evaluation of the functionality of the single hardware components is performed to a set of procedures.

This is to make sure that the instrument is working as optimally designed and is safe for use. The second part of the OQ is comprised of a set of Software Tests to verify that the installed software works reliably and correctly on the computer it was installed on.

Holistic Test (Performance Verification, PV)

Once testing of each individual component has been conducted, the entire performance of the system is proven by way of a holistic test (OQ-PV).

This is comprised of a series of ‘wet chemical’ tests, conducted utilizing reference materials, to validate systems is the capability to generate quality data, i.e., results that are precise, accurate and above all fit for the intended purpose.

On the basis of detailed, predefined instructions (SOPs), a series of conventional measurements are carried out, statistically evaluated and weighed up against the manufacturer’s specifications.

Differences Between Performance Verification (PV) and Performance Qualification (PQ)

Companies offers a set of tests known as the Performance Verification (PV) in order to confirm the instrument’s fitness for purpose. As previously mentioned, the PV is made up of standardized test procedures to guarantee optimal system operation in accordance with the manufacturer’s design in the selected environment.

On the other side, the Performance Qualification (PQ) qualification phase is extremely customer-specific .

PQ authenticates the fitness for the purpose of the instrument under in-situ conditions of use, demonstrating its continued suitability. It can be said, PQ tests are determined in line with the specific analysis and acceptance criteria.

Further questions to consider—is the analytical instrument qualified for its intended use? Is the lab in compliance with the latest regulations for equipment qualification and validation? For expert advice, contact a local Neutron and request a quote for Neutron qualification services today.

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EQUIPMENT CALIBRATION

Neutron IQ/OQ documentation was founded on the following documentation tree, 

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EQUIPMENT CALIBRATION

Regular calibration of instruments is commonplace for process manufacturers. But in the Pharmaceutical industry particularly

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TRAINING

These types of training methods do not make a full list, but they are the general methods that might be divided into sub-categories

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PROCESS VALIDATION

GMP validation is an element of quality assurance program for a pharmaceutical/biotech product or process.