Regulatory Compliance
Regulatory Compliance
The U.S. Food & Drug Administration (FDA); U.S. Drug Enforcement Agency (DEA); U.S. Environmental Protection Agency (EPA); Virginia Department of Health’s Division of Radiological Health & Safety; and the U.S. Federal Aviation Administration (FAA) have inspected EPL Archives (EPL).
In addition to regulatory inspections, EPL hosts quality assurance and compliance inspections throughout the year for clients in the pharmaceutical, chemical, petrochemical, agrichemical and cosmetic industries as well as various trade organizations.
The Quality Assurance Program at EPL oversees compliance with applicable regulations such as: Good Laboratory Practices (GLP); Good Clinical Practices (GCP); and applicable current Good Manufacturing (cGMP).
EPL complies with other industry best practices and proprietary standard operating procedures such as:
- ICH E6: Good Clinical Practice Guideline;
- Organisation for Economic Co-operation and Development (OECD) Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 15: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP;
- International Society of Biological and Environmental Repositories (ISBER);
- International Air Transportation Association (IATA); and
- Department of Transportation (DOT).
Contact us today and put EPL’s compliance to work for you.
