We maintain a rigorous QA program that includes regulatory and safety training, process audits, CAPA investigations, validation inspections, vendor qualification inspections, and facilities and equipment maintenance inspections.
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.
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.
We maintain and/or obtain certain permits, licenses, or compliance with other regulations in addition to applicable compliance with GLP, GCP, cGMP, and OECD and pertinent regulatory authorities holding jurisdiction:
- International Air Transportation Association (IATA);
- U.S. Department of Transportation (DOT);
- European Agreement for the International Carriage of Dangerous Goods by Road (ADR);
- Federal Motor Carrier Safety Administration (FMCSA);
- Unified Carrier Registration (UCR);
- Commonwealth of Virginia Controlled Substances Permit;
- U.S. Drug Enforcement Agency (DEA) Controlled Substance Permit;
- Convention on International Trade in Endangered Species (CITES);
- U.S. Fish and Wildlife Service;
- U.S. Department of Agriculture;
- Centers for Disease Control and Prevention; and
- U.S. Environmental Protection Agency.
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.