Info

VMRD's products fall into several categories: 1) kits we manufacture that are licensed by the United States Department of Agriculture (USDA) [VMRD's USDA Veterinary Biologics Establishment License Number is 332]; 2) reagents we manufacture that are not subject to licensure by the USDA; and 3) reagents manufactured for us by outside suppliers. All of the products that we sell are produced according to Good Manufacturing Practices (GMP), and undergo quality assurance (QA), quality control (QC) and continuous quality improvement (CQI) as indicated below. USDA-Licensed Test Kits: These are manufactured in compliance with stringent USDA guidelines and under USDA oversight. All USDA-licensed products have an Outline of Production approved by and on file with the USDA, as well as explicit written Manufacturing Operating Procedures (MOPs) in-house, which are reviewed by the USDA during their facility inspections. Both supplier and in-house raw materials are subjected to QA prior to inclusion into each lot of product. Before licensure, field testing is conducted in at least three independent laboratories and the raw and summarized data are submitted to the USDA. This testing includes a panel of samples of known reactivity for evaluation of tester interdependency. Each participating laboratory also supplies another panel of field samples which are also analyzed with a reference assay. All positive and discordant samples are retested with both assays. Discordant samples may be further analyzed by additional methods. In addition to field testing, the Master Seed and Master Cell Stocks (MCS) undergo rigorous testing both in-house, at an external laboratory licensed by the USDA, and at the National Veterinary Services Laboratory (NVSL, a subunit of the USDA). Only after this lengthy procedure (one to five years to completion), is a product license issued by the USDA. Even after licensure is granted, each and every serial (production lot) is tested in-house both before and after packaging, and by the USDA before serial release on a check set established by the USDA. Further, each serial is subjected to accelerated (37ºC) in-house stability testing. Finally, each serial is regularly tested in-house for quality assurance and stability ten times over the course of 24 months after serial release, a full year beyond the expiration date established by the USDA. These data are provided to the USDA to validate the expiration dating. Users of USDA-licensed test kits are advised to independently report any problems to the USDA as another means of ensuring quality. USDA requires that all sales be recorded by serial and has the authority to impose an immediate recall of any licensed product in the event that a problem occurs. In 25 years, VMRD has never had a compulsory regulatory product recall. Products are improved as market requirements and new scientific information evolve, but each improvement must be approved by the USDA and undergo rigorous performance and stability testing prior to incorporation into product for sale. Reagents Not Subject to USDA Licensure: All non-USDA-licensed products manufactured by VMRD are made in accordance with GMP and written MOPs. Quality control testing (also in accordance with written MOPs) is performed prior to packaging and post-packaging. Any serial not passing said testing is not released for sale. This testing is done by the Quality Control Department, which is a separate entity from the Production Department. A Certificate of Analysis, detailing the testing performed, is prepared for each serial. Permanent retention samples are maintained for each production serial, with ongoing testing being performed for as long as the serial is in inventory. Infrequently a question may arise as to performance (whether due to in-house testing or feedback from a customer) and an immediate moratorium on sales is triggered. Resumption of sales takes place only after sufficient testing has been done to validate current date performance of the product. Reagents Manufactured by Outside Suppliers: These products are subject to quality control testing by the manufacturers according to their internal policies. They are further tested upon receipt by VMRD in accordance with written MOPs, and a Certificate of Analysis is prepared. This is comparable to the post-packaging testing and all subsequent testing performed on VMRD-manufactured products. The quality control and assurance testing is performed as above, with the same restrictions. Maintenance of our USDA Veterinary Biologics Establishment License entails regular, un-announced inspections by the USDA of all research, production and manufacturing operations, including written documentation. All VMRD operations are performed in accordance with GMP, which includes explicit written documentation, including date performed and name of person performing the operation. Any changes to written procedure are also well-documented. All production and quality control computer documents are stored in protected directories accessible only with (very limited) permission. All written procedures are reviewed and updated on a regular basis, as are the aforementioned Outlines of Production on file with the USDA. VMRD has been in business for 25 years, and takes pride in its reputation as a manufacturer of high-quality veterinary diagnostics. We are committed to continuing to assess and improve the quality of our products in order to maintain that reputation. Should you require additional information or clarification, please do not hesitate to contact us.