GMP IQOQ

Don Whitley Scientific is dedicated to providing top-quality products and services to achieve and maintain compliance with the strictest Good Manufacturing Practice (GMP) standards. Our isolators are designed and manufactured to enable our customers to minimize risk, increase efficiency, and ensure regulatory compliance, all while maintaining the highest level of quality.

We recognize that GMP compliance is a critical concern for our customers, particularly in industries such as pharmaceuticals, biotechnology, and medical devices. That's why we offer a comprehensive range of isolator products and qualification services that are tailored to meet the specific needs of each customer. Whether you need a standard isolator or a customized solution, we have the expertise and resources to deliver exceptional products and services that exceed your expectations.

Our qualification services are based on scientific principles and industry best practices, following established protocols and procedures for Factory Acceptance Test (FAT), Site Acceptance Test (SAT) Installation Qualification (IQ), Operational Qualification (OQ), and Requalification (RQ). Our team of qualified experts uses state-of-the-art testing equipment and methodologies to perform comprehensive qualification services on our isolators, ensuring that they meet or exceed relevant industry standards, including ISO 14644, FDA cGMP, EU GMP Annex 1, and PIC/S guidelines.

We provide detailed reports that document the results of our testing, which enables our customers to demonstrate compliance with regulatory requirements and best practices.

Contact us today to learn more about our products and services, and how we can help you achieve your cGMP compliance goals.

More information on our validation documentation packages can be found in the Service & Accreditation section.