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Gibraltar Laboratories, Inc. is an independent, FDA-registered laboratory that provides services to the pharmaceutical industries.  Gibraltar Laboratories, Inc., as an independent contract testing laboratory, strives to fully comply with the appropriate regulatory requirements such as Current Good Manufacturing Practices as codified in 21 CFR Part 210 & 211 and when requested Good Laboratory Practices as codified in 21 CFR Part 58 or 40 CFR Part 160 or 792.

As an ISO 17025 accredited laboratory, Gibraltar is accredited for laboratory testing as identified on our A2LA Certificates.  Recently, the FDA has referred to laboratory accreditation in an industry guidance draft document.  Regulated products denied import into the United States by the FDA need to follow the guidance of the aforementioned document.  In the guidance document the FDA encourages importers to have testing performed at an accredited laboratory.
Historically, the enabling legislation is the Food and Drugs Act of 1906. It  was the first of more than 200 laws that constitute one of the world's most comprehensive and effective networks of public health and consumer protections. Here are a few of the congressional milestones:

• The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a legally marketed toxic elixir killed 107 people, including many children. The FD&C Act completely overhauled the public health system. Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.
• The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide tragedy in Europe (and the FDA's vigilance that prevented the drug's marketing in the United States), strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.
• The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.

Today, the FDA regulates $1 trillion worth of products a year. It ensures the safety of all food except for meat, poultry and some egg products; ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines and tissues for transplantation), medical devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer products that emit radiation do no harm.
Gibraltar is proud to serve the public’s health by being an independent provider of certification services with respect to microbiological and chemical compliance required by this Act and its amendments as specified in our written reports to our sponsors
More information can be found at the FDA’s web sites such as,
http://www.fda.gov/