Regulatory authorities expect pharmaceutical companies to have written standard operating procedures (SOPs) detailing the cleaning processes used for various pieces of equipment. If companies have one process for cleaning between different batches of the same product but use a different process for cleaning between product changes, regulatory authorities expect the written procedures to address these different scenarios.
With advances in analytical technology, residues from the manufacturing and cleaning processes can be detected at very low levels. We are proud to provide state of art instrumentation, services and consumables to support you on your path to GMP compliance.
The OneSource® UOQ program provides an instrumentation qualification program for maximum productivity and ongoing regulatory compliance capability. The program encompasses pharmacopeial (USP, EP, and JP) compliance with a design and approach that streamlines documentation across all major models of laboratory instruments, regardless of manufacturer.
OneSource Compliance Services ensures the highest levels of compliance with international regulations and guidelines. UOQ enables a seamless, cross-platform approach to a contemporaneous and automated documentation process, letting you gain immediate access to raw data from computer or database, for increased scientific productivity.
The LAMBDA™ 365 delivers state-of-the-art UV Vis performance that meets the needs of pharmaceuticals, analytical chemists in drug manufacturing QA/QC everywhere. With 21 CFR part 11 compliant software available, the LAMBDA system is ready to support everything from standard methods and applications to those requiring regulatory compliance.
Unleash the power of your LAMBDA UV/Vis spectrophotometer with UV WinLab software designed for operational simplicity and the power to address the most challenging analyses. Our Enhanced Security™ (ES) UV WinLab software is designed for busy pharmaceutical, manufacturing, industrial, food, or academic laboratories in regulated environments that require compliance with US FDA 21 CFR Part 11 regulations.
Our accessories, consumables, methods, and application support meet the most demanding requirements and are the preferred choice in thousands of laboratories globally.
We invest heavily in testing and validating our complete portfolio of solutions to ensure that you receive accurate, repeatable results – on-time, every time – throughout the lifetime of your instrument. We also offer a complete portfolio of specialized consumables that deliver reliable performance, control operating costs, and maximize the uptime of your instrument.