Compounding contract analytical laboratories

The EPA Contract Laboratory Program (CLP) has responsibility for managing the analysis programs required under the U.S. Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The approved analytical methods are designed to analyze water, soil, and sediment from potentially hazardous waste sites to determine the presence or absence of certain environmentally harmful organic compounds. The methods described here all require the use of GC/MS. 

Outsourcing the development, validation, and performance of analytical methods in recent years has become a popular means to facilitate movement of product through the development process. A recent industry survey reported that the vast majority (86%) of the companies responding say they outsource analytical methods development to contract laboratories. Twenty-five percent of the responding firms indicated that they often or always contract out stability testing on development compounds [37]. There are important criteria to follow in working with contract laboratories to ensure that their methods validation procedures yield results that are consistent with those of the client company [38]. This topic will be discussed later in this chapter. 

With the passage of the Resource Conservation and Recovery Act in 1976 and the Comprehensive Environmental Response, Compensation, and Liability Act (i.e., Superfund) in 1980, the United States Environmental Protection Agency (EPA) entered a new era in regulation. Due to these key environmental legislation acts, the EPA s list of hazardous compounds expanded, which placed additional burdens on the EPA s Contract Laboratory Program. Turnaround time from the contract laboratories was typically greater than 30 days [108] and this was not acceptable for the many critical and timely decisions that had to be made for the remediation of contaminated sites. Consequently, field-analytical methods were developed to supplement laboratory-analytical methods. 

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