Regulatory Compliance Made Simple

Today’s pharmaceutical companies are faced with a variety of regulatory requirements. FDA, USP, EP, and ASTM become an intimidating alphabet soup of red tape.

Dionex hardware, software, and services enable regulated labs to meet those requirements with a minimum of stress and pain. Our analytical RSLC, HPLC, and IC systems are designed to reliably operate within their published range of specifications. Chromeleon^® is a world leader in chromatography data security. The Dionex service and support organization is there with decades of experience. And they are there when you need them.

Dionex System Solutions Enable Full Regulatory Compliance

To meet FDA requirements in a regulated pharmaceutical laboratory is a daunting task, and Dionex is committed to assisting analytical chemists meeting these challenges. Whether it is instrument or software validation, Dionex offers solutions that meet the most demanding environments. The Chromeleon^® Data System software is designed to be implemented in a 21 CFR part 11 compliant fashion with a minimum of effort. Electronic signatures, audit trails, and restricted permissions are all features included in Chromeleon bundles with the GLP option.

Select Pharmacopeia Methods Based on Dionex Columns

Conforming to regulatory requirements often requires the use of analytical methods described in the national formularies found in the European (EP), United States (USP), and Japanese (JP) pharmacopeia. Dionex works hard with the various regulatory agencies to develop methods that are accurate and robust. A list of approved USP methods using Dionex columns is readily available.

Dionex Works with ASTM to Develop Analytical Methods

Water regulations address the analyte or contaminant, the maximum contaminant level (MCL), and the analytical method(s) that can be used to quantify the contaminant. Regulatory agencies such as ISO, ASTM, EPA, and AWWA have validated IC methods for the analysis of inorganic anions in drinking water.

Dionex works with regulatory agencies around the world to achieve solutions to the issues of water purity. We have developed analytical methods in conjunction with the US EPA, along with agencies in China, Japan, Korea, and international bodies ASTM and ISO. These methods, when used with Dionex instrumentation, provide reliable data on the purity of water which may be used for a variety of drug manufacturing processes.