regulatory & quality
Ethox STS quality system
Ethox STS is focused on meeting our customers’ requirements by delivering high quality products and technical services in compliance with both domestic and international standards. Over the years, our reputation as a customer-focused service organization, delivering excellence in quality and the highest level of customer service, has played a key role in our success in serving our customers.
Our clients benefit from over 40 years of outstanding quality and regulatory compliance.
All tests are conducted in accordance with applicable Quality System Regulation (QSR)/Good Manufacturing Practice (GMP) requirements and, when requested, in accordance as well with Good Laboratory Practice (GLP) regulations.
Our quality manual, quality system documents, and our extensive body of Standard Operating Procedures are key components of our corporate quality system. Routine internal auditing, trending, and management review of progress ensures continual improvement of the quality system, as well as accuracy and strict adherence to both the FDA and ISO requirements. This, in turn, enables Ethox STS and Ethox MMC to continue to deliver quality products and services to our customers.
| Current ISO Certifications: |
Rush NY Facility (Ethox STS):
• ISO 13485:2003
• ISO 11135 (EN 550)
• ISO 11134 (EN 554) |
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Erie PA Facility (Ethox MMC):
• ISO 13485:2003
• ISO 11135 (EN 550)
• ISO 11134 (EN 554) |
Ethox STS is registered with the Food and Drug Administration (FDA).
 The small-animal vivarium and animal care program at Ethox STS is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). This organization is a worldwide private nonprofit group that is dedicated to the promotion of humane treatment of animals in science, through a voluntary accreditation program. AAALAC accreditation, which Ethox STS has held since 1986, is a symbol of quality animal care within the scientific community. An AAALAC team performs a site visit every three years to assess the animal care program and to provide assistance with maintaining a quality program.
In addition to maintaining AAALAC accreditation, our vivarium program is inspected annually by the US Department of Agriculture, and the NY State Department of Health. Ethox STS is a member of the American Association for Laboratory Animal Science
guidelines
Ethox STS and Ethox MMC follow the regulations and guidelines of the following organizations:
Pharmacopoeial testing: EP, JP, USP
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