HyClone’s Quality System is based on compliance with current Good Manufacturing Practices (cGMP) for Medical Devices and ISO 9001:2000 guidelines.

HyClone regularly obtains completed and signed animal origin questionnaires from all suppliers of our raw materials and contact components. HyClone can determine which (if any) ingredients in a medium formulation are of animal origin or, if they have come in contact with animal-derived materials in manufacture. HyClone can also identify the tissue, species, and country of origin of those few materials that are animal associated.

HyClone maintains a database containing supplier information on mode of production and processing steps that reduce risk of adventitious animal agents. Through its Enterprise Resource Planning (ERP) software system, HyClone is able to generate formula-specific reports on all ingredients and components listed in a given Bill of Materials.

With heightened concerns in the industry regarding animal origin components, HyClone has taken the leadership role to obtain Certificates of Suitability from the European Pharmacopoeia for its serum products.

Certain of the quality information described on this page can be shared with customers subject to appropriate confidentiality assurances.

Quality Manual
Quality Assurance policies required for cGMP and ISO 9001:2000 compliance are summarized in HyClone’s Quality Manual. This manual is available for review upon customer audits of the HyClone facilities.

Audits
HyClone is subject to inspection by several regulatory agencies including the Food and Drug Administration and the United States Department of Agriculture. Continued conformance with ISO 9001:2000 is confirmed via biannual audits by SGS International Certification Services. HyClone invites customers from around the world to visit its manufacturing facilities in Logan, Utah (under appropriate confidentiality agreements). An audit team under the direction of Quality Assurance hosts auditing customers.

Document Control and Quality Records
HyClone maintains a validated electronic document management system, which controls all revisions, approvals and document security. Quality records are maintained to demonstrate compliance with specified requirements.