Quality Assurance

QUALIFIED INDEPENDENT OVERSIGHT

Quality Standards That
Positively Impact Performance

Our comprehensive quality assurance program provides qualified independent oversight of our  operations to maintain compliance with regulations and industry best practices. It also ensures that potential issues are identified and resolved quickly.

Quality Standards

Comprehensive Quality Standards

Our robust quality assurance program enables us to provide top-tier biostorage solutions and services you can trust.

GXP & OECD Compliant
Procedures

Professional Quality Assurance

Audit & Inspection Support

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Committed to Compliance

Our commitment to providing compliant solutions and services means you’ll never have to compromise quality on quality or efficiency.

Good Laboratory Practice (GLP)

Our biorepositories are compliant with applicable Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), the Organisation for Economic Co-operation and Development (OECD), and known industry best practices. These solutions support regulated product research and development, bioprocessing and manufacturing activities of sponsors and leading healthcare service providers domestically and internationally.

Compliance Defined

Our team maintains a rigorous Quality Assurance (QA) program that includes regulatory and safety training programs, research material inspections, internal quality assurance inspections, validation inspections, vendor assessment inspections, and equipment maintenance inspections.
Our QA program ensures compliance with applicable government regulations, internal Standard Operating Procedures, and known industry best practices and guidelines such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Current Good Manufacturing Practices (cGMP), Good Clinical Laboratory Practices (GCLP), Organisation for Economic Co-operation and Development (OECD).
Our restricted access facilities are purpose-built for the preservation of a wide range of regulated materials that require qualified storage environments that include but are not limited to: 21°C Controlled Ambient, Temperature, 2°C to 8°C Refrigerated, -20°C Frozen, -30°C , -40°C , and -80°C Ultra-Low, and -135°C or colder cryogenic storage.
We use specialized equipment that is approved and/or qualified for use throughout the execution of its established Standard Operating Procedures. Examples of this equipment include but are not limited to: facility security equipment to maintain restricted access, emergency backup equipment, emergency power generators, fire detection and suppression systems, validated systems for material management and environmental monitoring, and specialized material handling equipment.
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CONTACT

GXP-Storage LLC
5121 Kingdom Way, Suite 208
Raleigh, NC 27607
contact@gxp-storage.com

OPPORTUNITIES

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