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Chemical Laboratory Regulations

Regulatory compliances for Galbraith 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/]

British Pharmacopoeia (BP)

The British Pharmacopoeia s a collection of quality standards for UK medicinal substances. It is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.

Pharmacopoeial standards are publicly available and legally enforceable standards of quality for medicinal products and their constituents. The Pharmacopoeia is an important statutory component in the control of medicines which complements and assists the licensing and inspection processes of the Medicines and Healthcare products Regulatory Agency (MHRA) [1]of the United Kingdom.

Pharmacopoeial standards are compliance requirements, that is, they provide the means for an independent judgment as to the overall quality of an article and apply throughout the shelf-life of a product.

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

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/

Association of Official Analytical Chemists (AOAC)

Association of Official Analytical Chemists is a 120 year-old not-for-profit scientific association committed to worldwide confidence in analytical results. In fact, “worldwide confidence in analytical results” is AOAC’s vision.

To attain the vision, AOAC serves the communities of analytical sciences by providing the tools and processes necessary for community stakeholders to collaborate and, through consensus building, develop fit-for-purpose methods and services for assuring quality measurements. This is AOAC’s mission.

Leveraging the knowledge, experience, and expertise of more than 2,700 of its members with one-third of its members outside the US, AOAC has developed many competencies, programs, and a proven model to achieve its mission and vision and bring value to the analytical communities that AOAC serves. What do we mean by an AOAC community?

An AOAC community is a group of analytical scientists in a specific area who share AOAC’s vision of worldwide confidence in analytical results and who are brought together by a leader or “champion” to do together what they cannot do alone. Representatives of a community include scientific experts from various government agencies, industry, trade associations, international organizations, and academia. Following a proven AOAC model, stakeholders of a community work through consensus to prioritize methods needs, establish performance criteria for the methodology, and drive the development and validation of the best and most needed methods. The validation is conducted according to established and internationally recognized AOAC validation guidelines and this fact and recognition brings tremendous value to those who come to AOAC to validate methods. With 120 years of methods validation experience, we know how to do validation and have the ability to facilitate the development and approval of methods that promote trust and confidence in analytical results, thereby facilitating and promoting interstate and international trade, public trust in manufacturers’ products, and public safety and security.

Because confidence in analytical results also depends on other complementary tools, the community may opt to have AOAC qualify the laboratories doing the analyses, train the analysts, and provide proficiency testing.

Under the auspices of AOAC International, communities have the ability for open communications and decision making based on consensus, sharing of resources both financial and expertise, preventing duplication of efforts, and validating methods that are of outmost importance to the communities. The methods that result from the communities’ work are accepted internationally and are used by regulatory and industry scientists alike for many purposes including public health and safety, regulation, trade, monitoring, and quality control. AOAC has a number of communities in various stages of development including food safety and security, agricultural materials, marine and freshwater toxins, dietary supplements, food allergens, and disinfectants. The result of the work of AOAC communities, staff, and network of volunteers are AOAC® Official MethodsSM, the “gold standard” of methods accepted and recognized by regulatory agencies and organizations worldwide. In fact, many AOAC methods are specifically required in the enforcement of some state, provincial, municipal, and local laws and many federal food standards worldwide.

AOAC has official observer status in Codex Alimentarius since its inception allowing AOAC the ability to give input on the development of international standards for foods and agriculture. Because of AOAC’s proven recognition and credibility, if there is an AOAC method available, it generally will be accepted into a Codex standard. As of today, majority of the analytical methods cited in Codex standards are those of AOAC. With Codex being an organization supported by the World Health Organization (WHO) and Food and Agriculture Organization (FAO) of the United Nations, representing 168 countries worldwide, AOAC methods are recognized at the highest level in the world and thus generally the methods of choice by governments of those countries.

AOAC “Official Methods of Analysis” have been defined as “official” by regulations promulgated for enforcement of the Food, Drug, and Cosmetic Act (21 CFR 2.19), recognized in Title 9 of USDA-FSIS Code of Federal Regulations, and in some cases by the US Environmental Protection Agency.

[Courtesy of http://www.aoac.org/about/aoac.htm]

American Society for Testing Materials (ASTM)

American Society for Testing Materials is an international standards developing organization that develops and publishes voluntary technical standards for a wide range of materials, products, systems, and services. ASTM International develops standards using a consensus process.

ASTM International was formed in 1898 in the United States as the American Society for Testing and Materials by a group of scientists and engineers, led by Charles Benjamin Dudley, to address the frequent rail breaks plaguing the fast-growing railroad industry. The group developed a standard for the steel used to fabricate rails. It predates other standards organizations such as BSI (1901), DIN (1917) and AFNOR (1926), but differs from these in that it is not a national standards body, that role being taken in the USA by ANSI. However, it has a dominant role among standards developers in the USA, and claims to be the world's largest developer of standards.

Today, ASTM International supports thousands of technical committees, which draw their members from around the world and collectively maintain more than 12,000 standards. The Annual Book of ASTM Standards consists of 77 volumes.

Standards

The standards produced by ASTM International fall into four categories:

  • The Standard Specification, that defines the requirements to be satisfied by subject of the standard.
  • The Standard Test Method that defines the way a test is performed. The result of the test may be used to assess compliance with a Specification.
  • The Standard Practice that defines a sequence of operations that, unlike a test, does not produce a result.
  • The Terminology Standard, that provides agreed definitions of terms used in the other standards.

The quality of the standard test methods is such that they are frequently used world-wide, even in places where ASTM specifications are not used.

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

Some of the many ASTM Standard Test Methods routinely performed by Galbraith are in an abbreivated list below; please contact us to discuss our rull range of capabilities and your specific needs.

C136 Sieve Analysis of Fine and Coarse Aggregates
C25 Chemical Analysis of Limestone, Quicklime, and Hydrated Lime
C602 Standard Specification for Agricultural Liming Materials
D1045 Sampling and Testing Plasticizers Used in Plastics
D1084 Viscosity of Adhesives
D1120 Boiling Point of Engine Coolants
D129 Sulfur in Petroleum Products (General Bomb Method)
D130 Corrosiveness to Copper from Petroleum Products by Copper Strip Test
D1310 Flash Point and Fire Point of Liquids by Tag Open-Cup Apparatus
D1552 Sulfur in Petroleum Products (High-Temperature Method)
D2180 Active Oxygen in Bleaching Compounds
D2361 Chlorine in Coal
D2369 Volatile Content of Coatings
D2386 Freezing Point for Aviation Fuels
D2492 Forms of Sulfur in Coal
D2896 Base Number of Petroleum Products by Potentiometric Perchloric Acid Titration
D3172 Standard Practice for Proximate Analysis of Coal and Coke
D3176 Standard Practice for Ultimate Analysis of Coal and Coke
D3179 Nitrogen in the Analysis Sample of Coal and Coke
D3228 Total Nitrogen in Lubricating Oils and Fuel Oils by Modified Kjeldahl Method
D3643 Acid Number of Certain Alkali-soluble Resins
D3761 Total Fluorine in Coal by the Oxygen Bomb combustion/Ion Selective Electrode Method
D4017 Water in Paints and paint Materials by Karl Fischer Method
D4193 Thiocyanate in Water
D4239 Sulfur in the Analysis Sample of Coal and Coke Using High Temperature Tube Furnace Combustion methods
D445 Kinematic Viscosity of Transparent and Opaque Liquids (and Cal
D4603 Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
D473 Sediment in Crude Oils and Fuel Oils by the Extraction Method
D4749 Performing the Sieve Analysis of Coal and Designating Coal Size
D482 Ash from Petroleum Products
D5016 Sulfur in Ash from coal, Coke and Residues from Coal Combustion using High-Temperature Tube Furnace Combustion Method with Infrared Absorption
D5058 Compatibility of Screening Analysis of Waste
D513 Total and Dissolved Carbon Dioxide in Water
D5142 Proximate Analysis of the analysis Sample of Coal and Coke by Instrumental Procedures
D5373 Instrumental Determination of Carbon, Hydrogen, and Nitrogen in Laboratory Samples of Coal and Coke
D56 Flash Point by Tag Closed Cup Tester
D5865 Gross Calorific Value of Coal and Coke
D6349 Determination of Major and Minor Elements in Coal, Coke, and Solid Residues from Combustion of Coal and Coke by Inductively Coupled Plasma–Atomic Emission Spectroscopy
D664 Acid Number of Petroleum Products by Potentiometric Titration
D803 Testing Tall Oil
D808 Chlorine in New and Used Petroleum Products (Bomb Method)
D92 Flash and Fire Points by Cleveland Open Cup Tester
D93 Flash Point by Pensky-Martens Closed Cup Tester
D94 Saponification Number of Petroleum Products
D95 Water in Petroleum Products and Bituminous Materials by Distillation
D984 Reducible Sulfur in Paper
E28 Softening point of Resins Derived from Naval Stores by Ring-and-Ball Apparatus
E778 Nitrogen in the Analysis Sample of Refuse-Derived Fuel
E828 Designating the Size of RDF-3 From its Sieve Analysis

Technical Association of the Pulp and Paper Industry (TAPPI)

The Technical Association of the Pulp and Paper Industry is the leading association for the worldwide pulp, paper, packaging, and converting industries and co-publisher of Paper360°. Through information exchange, trusted content, and networking opportunities, TAPPI helps members elevate their performance by providing solutions that lead to better, faster, and more cost effective ways of doing business.

Founded in 1915, TAPPI has grown into the world’s largest professional association serving the pulp, paper, converting and packaging industries. TAPPI’s members look to the association for information, education, and knowledge-sharing opportunities.

TAPPI’s Mission is to engage the people and resources of our Association in providing sound solutions to the workplace problems and opportunities that challenge our current and future members. And, TAPPI’s Vision is to make a significant positive difference in the professional lives of our members.

TAPPI serves four distinct segments of the global industry: pulp and paper technical, pulp and paper operations, converting and packaging, and suppliers and consultants. Recently, the Association has expanded its reach within the pulp and paper industry to the operations area, providing value throughout the production chain. At the same time, TAPPI remains committed to providing the vital forum that more technically focused scientists and engineers need and expect from TAPPI as they work to discover the innovative solutions our industry needs. TAPPI is committed to helping pulp and paper manufacturers improve their manufacturing operations, enrich their workforce, and shape our industry’s future.

TAPPI has served the converting and packaging industry for many years. Currently, the Association is working to build on its successes in both the corrugated packaging and the flexible packaging areas by focusing dedicated resources and building innovative new products and services to meet the specific needs of people in the converting and packaging industry.

Through TAPPI, suppliers and consultants working in the pulp, paper, packaging, and converting industry have unparalleled opportunities to contribute their technical expertise to the industry; to achieve their company’s objectives, and to develop their core competencies through professional development, education, and training.

For over 90 years, TAPPI has been a resource and a solution for the entire industry, helping members and countless individuals and companies throughout the global pulp, paper, packaging, and converting industry advance to a higher level of performance.

[Courtesy of http://www.answers.com/topic/tappi]