IQ OQ PQ for Pharmaceutical
What Is IQ OQ PQ?
In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.
What Do IQ, OQ and PQ Mean?
IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.
Installation Qualification (IQ)
Installation qualification, or IQ, is a documented verification process that the instrument or piece of equipment has been properly delivered, installed and configured according to standards set by the manufacturer or by an approved installation checklist.
Installation qualification requirements for equipment include checking for proper location, proper energy supply and acceptable environmental conditions. There is also checking of contents against the packing list, verifying software installation, documenting computer-controlled instrumentation, verifying connections with peripherals, and recording calibration and validation dates, among others.
Operational Qualification (OQ)
Operational qualification is the next step in quality assurance and involves testing the equipment and making sure it performs as specified, within operating ranges as listed by the manufacturer. All aspects of the equipment receive individual testing and the tester documents the proper operation of each.
Operational Qualification for equipment is necessary after installation, significant maintenance or modifications to the equipment, or as a feature of scheduled quality assurance testing. Operational qualification aspects that will be tested may include leveling and fluctuation, repeatability, keyboard controls, deviation reports, calibration and certificates, as well as performance reports.
Performance Qualification (PQ)
Before your equipment can be truly rated as qualified, you will need to put it through performance qualification. Your process performance qualification protocol will feature verification and documentation that all equipment is working within the accepted range as specified, does it perform as expected under real conditions. All instruments are tested together according to a detailed test plan and must generate reproducible results.
Performance qualification protocols and validation should typically include but not be limited to:
- Data summary — A list of data that needs to be analyzed or recorded during the testing procedure
- Manufacturing conditions — Such as component inputs, operating parameters and equipment environment
- Calibration and validation
- Sampling plan — What sampling methods are used (if applicable)
- Analysis methodology
- Variability limits
- Nonconformance contingencies
More on Quality Assurance for Your Pharmaceutical Equipment with Precision Solutions, Inc.
Consumer confidence is more vital in the pharmaceutical industry than in almost any other industry. When asking people to put their lives and their health in your hands, you need to give them every reason to have complete faith in your products. Precision Solutions, Inc. has Certified Weighing Technicians trained to work with your IQ OQ and PQ validation within USP 41 Standards. Partnering with industry leaders such as Sartorious, Minebea and Ohaus you can ensure we’ll have the right equipment for your lab and it will be properly validated.
By enforcing extensive and comprehensive IQ, OQ and PQ protocols in your business, it’s more likely you have equipment that is consistently accurate, reliable and high quality. This means you are better able to produce products your customers can rely on.
For reliable, accurate measuring and testing equipment for your pharmaceutical needs, contact Precision Solutions Inc. today.