IQ, OQ, PQ: Essential Steps for Equipment Qualification

Introduction – Activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly” is what the FDA defines as “qualification.” These tasks must be completed before products are manufactured on a commercial basis. Installation qualification (IQ), operational qualification (OQ), and performance qualification are the three stages of qualification (PQ). The FDA enforces several sections of 21 CFR 211 (pharmaceuticals) and 21 CFR 820 (medical devices), which address validation and the related certification procedures. This equipment is located at various supply chain stages, from packing facilities akin to Amazon to intricate, futuristic laboratories. One thing unites them all: equipment failures at any stage of the supply chain can lead to a dangerous product failure, including mislabeled goods, incorrect dosage, wrong formulation, unsealed or unhygienic goods, and more. The acronym IQ OQ PQ stands for equipment quality assurance gold standard. During the three stages of installation, this method applies quality assurance requirements to crucial equipment. One major obstacle a pharmaceutical company must overcome to comply with regulations is IQ OQ PQ.

Describe the V-Model.

The relationship between the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) conducted on the user requirements, functional design, and detailed design is visualized and compared using the V-model technique (see picture below).

In the pharmaceutical manufacturing sector, what does IQ OQ PQ mean?

Installation Qualification, Operational Qualification, and Performance Qualification are IQ OQ PQ. These three steps verify and record that the utilities (steam, water, and air), pipelines, instrumentation, and other equipment are installed appropriately, function as intended, and meet design specifications. These procedures aim to establish a paper or electronic evidence trail with several signatures from all pertinent departments—such as validation, engineering, maintenance, calibration, and quality assurance. This documentation demonstrates to the (owners, clients, or regulatory authorities) that the system is operating according to the engineering drawings and design specifications and that the necessary equipment has been delivered, installed, and configured appropriately.

The IQ, OQ, and PQ procedures are required by the GMP system for the equipment qualification process. It aids producers in ensuring that the machinery consistently produces high-quality results. In addition, each of these procedures significantly reduces errors, allowing for the maintenance of product quality in compliance with industry standards and applicable laws. Equipment qualifying might be done internally or by consulting experts providing equipment validation services.

Why is Qualification (IQ OQ PQ) Required in the Lifescience Sector?

The engineering team, the validation team, or any other individual or group with the necessary skills and expertise to carry out the tasks, as well as someone trained and informed about the use and operation of the equipment, typically completes the qualification process.

Two primary causes.

1)The first justification is that it’s required by law.

The Food and Drug Administration (FDA) claims that – To enable operations for both its intended use and for cleaning and maintenance, equipment used in the manufacture, processing, packing, or holding of a drug product must be of an appropriate design, an adequate size, and a suitable location. 211.63, 21 CFR Title. In the EU, more thorough qualification guidelines are available in EudraLex – Volume 4 – Good Manufacturing Practice (GMP), part of Annex 15: Qualification and Validation. Furthermore, even if it isn’t a rule, the ISPE Baseline Guide 5 Commissioning and Qualification (Second Edition) is a popular qualification guide that has the approval of several regulatory bodies.

2) The second rationale is that during the certification and validation of a new facility or procedure

We understand that even the slightest installation mistake or minor equipment malfunction can have fatal repercussions for patients due to a significant product quality issue that cascades and escalates. This issue is severe with unique or new systems because there is no performance history, and even minor issues might result in patients becoming ill or dying.

Installation Qualification (IQ): What is it?

Installation Qualification (IQ) is a crucial, documented procedure that guarantees the proper delivery, installation, and configuration of instruments, software, pipelines, and other equipment critical to the quality of the final product. This procedure acts as a comprehensive check against a pre-established checklist to guarantee that all components that have been installed meet installation guidelines and design parameters, whether these are established by the manufacturer or using an authorized checklist. When installing new machinery, for example, IQ helps ensure that the instruments you specified in the detailed design specifications have been shipped and installed correctly, that the equipment is made of suitable materials, and that it is installed in the proper location with all connections, such as pipework and electrical wiring, adequately set up. Experts in their fields, like validation technicians, commissioning and qualification (C&Q) engineers, or commissioning, qualification, validation (CQV) engineers, usually conduct this thorough inspection. The first step is this. The engineering department will work with QA and users to develop the equipment’s IQ document. The purpose of IQ is to verify that the buildings housing the utilities and equipment have been constructed and set up by the authorized design specification (DQ) and the guidelines and advice provided by the manufacturer.

What contributes to IQ’s success?

Contrasts what was “found” at the location with what was “specified.” Recordings of any noncompliance found during installation certification are required.

• Comparing the delivery to the packing lists and looking for damage.
• Ensuring that equipment specifications meet design and operational requirements.
• Verifying that components are identified accurately and that serial numbers, makes, and models are accurate.
• Confirming that secondary and auxiliary equipment has been installed correctly and the connections to other units and installation sites.
• Verifying that functioning and environmental conditions adhere to manufacturer specifications and checking the energy or utility supply.
• Capturing firmware versions and serial numbers and confirming software installations.
• Assembling all relevant manuals and certificates, as well as recording the dates of calibration and validation.

Conclusion – IQ, OQ, and PQ phases ensure equipment quality in pharmaceutical manufacture. These stages verify proper installation, reliable operation, and satisfaction of user requirements. This procedure is required by regulations, which guard against risks, including incorrect doses or mislabelled products. Requalification regularly guarantees continued compliance and quality. Sophisticated direction can simplify verification procedures and preserve stable, conforming systems.