Horiba launches new A-TEEM Compliance Package, designed to meet the regulatory requirements of the pharmaceutical industry. The package offers a complete record-keeping, method validation, and instrument verification solution to meet worldwide GMP and Electronic Records requirements.
The package is comprised of 3 elements:
- The EzPAT server, developed under OPC UA protocols, provides connectivity with common PAT enterprise platforms that are used to control process analytics while enabling regulatory compliance. Deployed on the HORIBA Aqualog®, EzPAT enables the OPC UA client to control A-TEEM data acquisition, analysis, and prediction as part of a larger environment that ensures regulatory control.
- Our A-TEEM Direktor multivariate analysis software is the first MVA package explicitly designed for multidimensional A-TEEM data. It was developed with non-expert users in mind and provides a guided workflow that allows beginners to succeed quickly. Knowing that it may be deployed in a GMP environment, the software was developed following GAMP (Good Automated Manufacturing Practice) guidelines. It provides a complete audit trail, includes authentication by user login, and other controls needed to enable compliance with electronic records guidelines, such as 21 CFR Part 11.
- IQ/OQ documentation and qualification specifically designed to follow U.S. Pharmacopeia test methods. Acceptance criteria ensure data reliability, reproducibility, and meeting expected performance standards.
A-TEEM combines UV-Vis Absorbance-Transmittance with fluorescence Excitation Emission Matrix spectroscopies and is faster, and more sensitive, with lower detection limits than current PAT spectroscopic solutions. With this new compliance package, A-TEEM is the spectroscopic solution that can identify low-level components in complex mixtures, flag contaminants, and identify the out-of-spec product, with end-to-end coverage for a GMP environment.
A-TEEM combines the sensitivity of separations with the speed of spectroscopy. It dramatically expands the analytical toolbox for monitoring samples challenging for PAT – like vaccines, ADCs, viral vectors, and exosomes. With the addition of this compliance package, A-TEEM can move seamlessly from R&D to production.