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At McCrone Associates, we are committed to providing you with the highest quality of service possible. Our comprehensive Quality Laboratory Practices (QLP) program defines and documents our mission, objectives and policies.
McCrone Associates 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 broadly designed to meet or exceed a wide range of regulatory standards and requirements, whether pharmaceutical related, manufacturing defects or potential litigation. ISO 17025:2005 and 21 CFR Parts 210, 211 and 820 have been used as guidelines in the development of the McCrone QLP program and are clearly reflected in our current company policies and practices. To ensure cGMP compliance, McCrone Associates is registered with the FDA as an Analytical Laboratory. McCrone Associates has received no 483’s following the last two FDA audits. Additionally, we make our QLP program available for client review and we are routinely audited by clients (approximately 25 per year) to ensure current practices meet or exceed all the client’s quality needs and requirements.
McCrone Associates is a DEA licensed agent capable of handling Schedule I-VII controlled substances.
The QLP program is the responsibility of the Quality Manager and the Quality Assurance Unit, and is fully supported by the executive staff of McCrone Associates. The laboratory management ensures that these policies and objectives are communicated to, understood by and implemented by all administrative and laboratory personnel concerned.