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Regulatory Compliance

Regulatory Compliance for Galbraith Gas Chromatography Gas Chromatography & Chemical Testing Laboratory

Galbraith’s regulatory and standard method expertise is in direct proportion to the wide variety of business and industry we serve.

Food and Drug Administration – Good Laboratory Practices (FDA – GLP)

Non-clinical laboratory studies are experiments in which test articles (food additives, color additives, drug or biological products, electronic products, medical devices for human use) are studied in test systems (animals, plants, microorganisms, or subparts thereof) under laboratory conditions to determine their safety. The Food and Drug Administration (FDA) regulates the conduct of non-clinical laboratory studies under Part 58 (Good Laboratory Practice for Non-clinical Laboratory Studies) of Title 21 of the Code of Federal Regulations. Galbraith has the capabilities to perform analyses in support of these non-clinical laboratory studies. All data generated as part of this study is thoroughly reviewed by the Quality Assurance Unit (QAU). In addition to a compliance statement on the analytical report, the QAU will prepare a Quality Assurance statement for the Study Director and his or her management that will provide supplemental detail about the inspections and audits that were conducted in support of the study.

For Additional information: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1

Current Good Manufacturing Practice (cGMP)

Good Manufacturing Practices, also referred to as 'cGMP' or 'current Good Manufacturing Practice', is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of pharmaceutical products. GMP is governed by the Code of Federal Regulations (21 CFR 210 and 211 as well as 21 CFR 792.) Galbraith routinely analyzes products for hundreds of clients that are governed by these regulations. The Quality Assurance Unit inspects all data generated to ensure that these analyses comply with all applicable regulations. Galbraith also has a comprehensive instrument validation system to ensure that all instrumentation used in support of these studies is fully qualified. For a full description of requirements for these regulations, please visit the following link: http://www.fda.gov/cder/dmpq/cgmpregs.htm

United States Pharamcopeia – National Formulary (USP/NF)

The United States Pharmacopeia–National Formulary is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.

The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as the official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding. The USP–NF is also widely used by manufacturers wishing to market therapeutic products worldwide. Meeting USP–NF standards is accepted globally as assurance of high quality.

[Courtesy of http://www.usp.org/USPNF/]

Japanese Pharmacopoeia (JP)

The Japanese Pharmacopoeia provides the official Japanese standard for the description and quality of drug substances and products.

The Japanese, United States and European Pharmacopoeias are the major pharmacopoeias in the world. They have established regular lines of communication and have set up a program that is working towards the harmonization of monographs and standards.

[Courtesy of http://www.rt-corp.com/products/c305.aspx]

European Pharmacopoeia (EP)

The European Pharmacopoeia is a listing of a wide range of active substances and excipients used to prepare pharmaceutical products in Europe. The 2005 edition includes 1800 specific and general monographs, including various chemical substances, antibiotics, biological substances; Vaccines for human or veterinary use; Immunosera; Radiopharmaceutical preparations; Herbal drugs; Homoeopathic preparations and homoeopathic stocks. It also contains Dosage forms, General monographs, Materials and Containers, Sutures; 268 General methods with figures or chromatograms and 2210 reagents are described.

[Courtesy of http://en.wikipedia.org/wiki/European_Pharmacopoeia]

On 22 July 1964, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom signed a Convention, under the auspices of the Council of Europe, on the elaboration of a European Pharmacopoeia.

The objectives are to harmonize specifications for medicinal substances which are of general interest to the peoples of Europe and to hasten the drawing-up of specifications for the growing number of new medicinal substances appearing on the market.

These objectives are attained by creating a European Pharmacopoeia made up of monographs which become official standards applicable in the territories of the Contracting States.

On 16 November 1989 a Protocol to the Convention was signed which enabled the European Community to accede to the Convention. The Protocol entered into force on 1 November 1992.

A total of 32 European countries are now party to the Convention:

The European Pharmacopoeia is drawn up by two bodies:

[Courtesy of http://europa.eu/scadplus/leg/en/lvb/l21161.htm]

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

The primary focus of Federal Insecticide, Fungicide, and Rodenticide Act was to provide federal control of pesticide distribution, sale, and use. EPA was given authority under FIFRA not only to study the consequences of pesticide usage but also to require users (farmers, utility companies, and others) to register when purchasing pesticides. Galbraith has the capabilities to participate in these studies. The technical staff and Quality Assurance Unit work in conjunction to ensure that all your regulatory analytical needs are met. The regulations that govern this Act can be found at the following link: http://www.access.gpo.gov/nara/cfr/waisidx_06/40cfr160_06.html

Resource Conservation and Recovery Act (RCRA)

The Resource Conservation and Recovery Act is an amendment to the 1976 Solid Waste Disposal Act. The goals of RCRA are to:

Galbraith has the capability to support a study that requires RCRA oversight. A fully staffed Quality Assurance Unit and an experienced technical staff will ensure that all the regulatory requirements for a study of this type are met. Galbraith is very experienced in providing analytical support for a variety of difficult matrices and has the ability to choose from a wide variety of methods to meet your analytical needs. For additional information regarding the RCRA regulations, please visit: http://www.epa.gov/rcraonline/

Toxic Substances Control Act (TSCA)

The Toxic Substances Control Act of 1976 was enacted by Congress to give EPA the ability to track the 75,000 industrial chemicals currently produced or imported into the United States. EPA repeatedly screens these chemicals and can require reporting or testing of those that may pose an environmental or human-health hazard. EPA can ban the manufacture and import of those chemicals that pose an unreasonable risk. Galbraith has the technical and regulatory expertise that is needed to fully support a study that is governed by this regulation. The Quality Assurance Unit will ensure that all data that is released is fully supportable and meets the requirements of these regulations. Additional information regarding this Act can be found at the following link: http://www.access.gpo.gov/uscode/title15/chapter53_.html

Nuclear Regulatory Commission (NRC)

The Nuclear Regulatory Commission is a United States government agency that was established by the Energy Reorganization Act in 1974, and was first opened January 19, 1975. The NRC took over the role of oversight of nuclear energy matters and nuclear safety from the AEC, or Atomic Energy Commission. The oversight of nuclear weapons, as well as the promotion of nuclear power, was transferred to the Energy Research and Development Administration by the same act, thereby eliminating the AEC (in 1977, ERDA became the United States Department of Energy). Galbraith can conduct analytical work that is in compliance with those aspects of the NRC regulations that apply to subcontract analytical laboratory. Specifically, the following regulations apply to the work that Galbraith is able to perform: 10 CFR 21, 10 CFR 60 (Subpart G and Subpart H, and 10 CFR 72 (Subpart G). Our Quality Assurance Unit provides the oversight required to ensure that all analytical data is fully supportable. For additional information regarding those regulations that govern the nuclear industry, please visit the following link: http://www.nrc.gov/reading-rm/doc-collections/cfr/