McCrone Associates is committed to providing the highest quality service to our diverse group of clients. McCrone defines its mission, objectives and policies in a Quality Laboratory Practices (QLP) Program, which explains our commitment to total quality. Our QLP Program is comprehensive, dynamic and designed to encompass all our client’s needs. The elements of this system, designed to focus on our clients' need for correct answers to clear questions and good solutions to unique problems, are documented in our QLP Program. McCrone does not manufacture, process, pack or hold drug products, conduct animal studies, perform toxicity testing of regulated products, nor issue calibration "certificates" (other than our reports); therefore, our quality system is appropriate to the type, range and volume of testing activities undertaken. McCrone’s QLP is based primarily on the FDA’s cGMP requirements, however, because these requirements are nearly universal, McCrone’s quality program reflects the standards expected from ISO17025 as well.

McCrone offers a unique service, different than most contract laboratories, because we offer more than standard operating procedures (SOP’s) and electronic reports. We offer cumulative knowledge and experience; and, we provide total quality service using unparalleled micro-analytical resources, exceptional skills, valuable data, personal consultation, and narrative reports mostly on non-routine problems. Although the majority of analyses we perform are of a non-routine nature, the functionality of the lab is dictated, wherever possible, by SOP's. All findings are verified by a 100% technical (peer) review.

McCrone Associates is registered with both the FDA and DEA. In addition to internal audits, McCrone is routinely audited by its clients as well as the FDA. McCrone Associates has demonstrated through on-site audits its compliance with the FDA’s GMP and ISO17025 standards that meet our clients’ sub-contractor requirements.

The QLP program is maintained current as part of the responsibilities of the Director of Quality Assurance. The laboratory management ensures that these policies and objectives are communicated to, understood, and implemented by all administrative and laboratory personnel concerned.