To ensure complete regulatory compliance, PMI’s Institutional Animal Care and Use Committee (IACUC) reviews all new protocols prior to acceptance. All work must comply with 21 CFR, Part 58, Good Laboratory Practice (GLP) guidelines, and the company maintains required registration with the United States Department of Agriculture, the National Institute of Health, the Food and Drug Administration, and the Drug Enforcement Administration. Our San Carlos facility received full accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) in 2008.
Our compliance department performs periodic inspections to ensure that PMI’s facilities, equipment, practices, records and personnel adhere to GLP guidelines, SOPs and protocols. An extensive review of the submitted GLP protocol is performed before approval. The compliance unit conducts critical phase inspections and audits during the in-life portion of the study and reviews and approves all records/data along with the draft and final report before submission.
Our compliance department stays current with industry standards by attending conferences, participating in webinars and online training programs. We recommend that clients preparing for a GLP study should schedule an audit of our facility in order to gain complete comfort and reassurance that our practices and procedures meet GLP guidelines. Our friendly and experienced staff will provide you with all the information you need to feel confident in scheduling your GLP study at PMI.