Regulatory

Quality is engrained in all that PHB does and the products that we create. Maintaining a commitment to excellence extends throughout our processes, quality standards, accreditations, and regulatory requirements. We’re proud to adhere to and carry the following certifications and registrations.

FDA

The Food and Drug Administration serves as the oldest consumer protection agency in the United States government, as a part of the Department of Health and Human Services. Each year, PHB works with the FDA to provide information on specific products that involve the design, production, manufacturing, promotion, labeling, and testing of regulated products. Additional guidance documents are provided in which the content, processing, and evaluation or approval of submissions, as well as inspection and enforcement policies.

USDA-APHIS

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) established the International Animal Product Export Regulations (IREGS) to provide exporters the requirements for importing animal-origin products for specific countries. APHIS primarily serves to provide export certification about the animal health status of the region of origin of the product.

ISO 9001:2015

Receiving the ISO 9001:2015 Certificate means that PHB has met or exceeded the international standard that specifies requirements for a quality management system (QMS). Companies utilize this standard to demonstrate that they have the ability to consistently manufacture products and provide services that meet or exceed both customer and regulatory requirements. Proliant Health & Biologicals is proud to have received its ISO 9001:2015 Certificate for its Boone facility. To view the certification, please click here.

TRACES

Trade Control and Expert System (TRACES) is the European Commission’s system to control certification required for the importation of animals, animal products, food, and feed and plants into the European Union. TRACES is used for three main reasons: exchange of information and data; traceability; and risk management. Ultimately, it exists to enhance food safety, reduce the impact of disease outbreaks, and can mean quicker response times to address certain serious risks throughout the agri-food chain.

EDQM

The European Directorate for the Quality of Medicines (EDQM) checks compliance with both Good Manufacturing Practice (GMP) and the application of the Certificate of Suitability (CEP) at the manufacturing and distribution sites covered by CEPs. It serves as a leader to protect the access of good quality medicines and healthcare for both humans and animals.