Environmental News - Spring 2009

EPA test methods support Pharmeceutical Operations

Environmental NEWS - Spring 2009

EPA test methods support Pharmaceutical Operations

As one of the largest contract laboratories in the country, Lancaster Laboratories provides comprehensive analytical services in the environmental, pharmaceutical and biopharmaceutical sciences. While the clients for the two latter categories are almost exclusively Pharmaceutical and related firms, the testing performed in the Environmental Sciences departments supports a wide variety of industries, from local municipalities to world wide petrochemicals companies. Not surprisingly, there is some crossover between the client lists for the three divisions.

Pharmaceutical clients typically require testing to meet USFDA requirements, but there are some applications for USEPA methods to support their development and manufacturing operations.

Monitoring of plant effluent for contaminants specifically related to pharmaceutical manufacturing operations is one example where Lancaster Laboratories’ Environmental Sciences departments can help pharmaceutical clients meet government regulations.

The Pharmaceutical Effluent Guidelines (PEG), found in 40 CFR Part 439 include nontraditional analytes and analytical methods specific to the industry. The monitoring requirements are based on the type of operations at the facility, and Lancaster Laboratories is capable of testing for all of the contaminants listed in the regulation. The contaminant list and more information about the regulations are available here.

Verifying the purity of plant influent and drinking water used for toxicology testing is another niche that Lancaster Laboratories can fill for pharmaceutical clients. USFDA Good Laboratory Practice (GLP) regulations require that water supplied to animals used in testing within the scope of GLPs must be analyzed periodically to ensure that contaminants known to be capable of interfering with the study are not present in significant levels.

Since Lancaster Laboratories is certified to perform drinking water analysis, firms with animal facilities can request testing in support of GLP projects with the assurance that they are using a firm with experience and expertise in the test methods.

In addition, the standard operating procedures for documentation, instruments and personnel used in the Environmental Sciences laboratories include the requirements of the GLP regulations, and if strict GLP compliance is requested, Lancaster Laboratories’ Quality Assurance Unit has procedures in place to provide the extra oversight required in the GLP regulations. Because projects requiring strict GLP compliance involve more up front planning than typical projects, communication with the laboratory about the project requirements is paramount to a successful outcome.

For more information please contact us at env@lancasterlabs.com.