Compliance

The quality program at GXP ensures compliance with applicable government regulations, internal Standard Operating Procedures, and 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).

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 GXP in North America. Our European location is inspected by the Agence Nationale de Sécurité du Médicament (ANSM) (human pharmaceuticals agency) and the Comité Français d’Accréditation (COFRAC) (for the GIPC regulating other chemicals).

In addition to regulatory inspections, we host 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.

Our restricted access facility is purpose-built for the preservation of a wide range of research and manufacturing materials that require qualified storage environments that include but are not limited to: +21°C Controlled Room Temperature, +4°C Refrigerated, -20°C Frozen, -80°C Ultra-Low and -196°Cryogenic Liquid Nitrogen storage. For paper and other data, stored on physical electronic media, GXP also provides humidity-controlled environments to optimize long-term preservation. These storage environments are monitored by a validated environmental monitoring system and supported by dedicated Facility Management, Quality Assurance and Emergency Response teams.

GXP utilizes 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, specialized material handling and testing equipment and mirrored computer servers to ensure the secure long-term preservation of our clients consolidated research and manufacturing material.

We provide quality program training to all its personnel that includes but is not limited to: Standard Operating Procedures, applicable regulatory training; laboratory safety; universal precautions; chemical hygiene; blood-borne pathogens; controlled substances; radiation safety; and hazardous material handling and shipping.

GXP has developed its training material over time and may also use certain external experts to provide training. All GXP personnel maintain training documentation to demonstrate their on-going commitment to excellence.

GXP’s validated 21 CFR Part 11 compliant material management system provides a consolidated view of highly diverse research, development, and manufacturing material as well as related data.

Our clients use the GXP secure web portal to manage their consolidated material and data. These clients use the account-based search, filtering, and virtual collection capabilities to rapidly respond to internal requests that support ongoing research and development activities.

We also use a robust environmental monitoring system that is also validated and U.S. FDA Title 21 CFR Part 11 compliant. This system allows GXP to monitor the environment where client research and manufacturing material is managed for secure long-term preservation and is part of GXP’s multi-channel alert and alarm notification procedures to ensure communication with designated Emergency Response team members.