Compliance: The act of adhering to, and demonstrating adherence to management laws, regulations or policies

Control of Substances Hazardous to Health (COSHH): UK regulations about the handling of chemicals in the workplace. A COSHH form are required to be supplied with any chemicals to where it is delivered and always be available to all members of staff handling it. It contains guidelines on what should be done if the chemical comes into contact with skin and other safety precautions, plus the normal "Irritant", "Flammable" or other chemical and biochemical hazard warnings.

Directive 91/356: regulation defining the information to be contained on labels including:  Sponsor’s name and contact details; Pharmaceutical dosage; form of the drug; Route of administration; Quantity of dosage units; Name/identifier and strength/potency (open trials only); Batch and/or code number to identify contents and packaging; Trial reference code identifying trial, site, investigator and sponsor; The name of the investigator; Directions for use; Storage conditions; Period of use in clear month/year format; Keep out of reach of children.

Globally Harmonised System of Classification and Labelling of Chemicals(GHS):  Set to replace the various different labeling standards for hazardous chemicals used in different countries. GHS includes a set of hazard symbols that replaces the European orange-colored hazard symbols and American equivalents. The symbols are similar to the EU symbols, with exceptions, but include a new area for hazards to humans such as carcinogens, mutagens, sensitizers and substances which have target organ toxicity. These insidious biological hazards are now separated from acute chemical toxicity.

Good Clinical Practice (GCP): International quality standard provided by the International Conference on Harmonisation (ICH) that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. The guidelines define the standards which trials are conducted including the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. They also include protection of human rights as a subject in clinical trial as well as provide assurance of the safety and efficacy of the newly developed compounds.

Good Distribution Practice (GDP): Guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Good Laboratory Practice (GLP): a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, cosmetics, food and feed additives and contaminants, novel foods and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

Good Manufacturing Practice (GMP): Regulatory framework governing the control and management of manufacturing and quality control testing of foods and pharmaceutical products. An important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment have been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).

Good Automated Manufacturing Practice (GAMP): is a set of guidelines laid down by International Society of Pharmaceutical Engineering (ISPE) covering the use of automated manufacturing and electronic tracking systems within the pharmaceutical industry.

Health Level Seven (HL7): An all-volunteer, not-for-profit organization involved in development of international healthcare standards. “HL7” is also used to refer to some of the specific standards created by the organization (i.e. HL7 v2.x, v3.0, HL7 RIM etc.). HL7’s primary mission is to create flexible, low-cost standards, guidelines, and methodologies to enable the exchange and interoperability of electronic health records.

International Organization for Standardization (ISO): an international standard-setting body for industrial and commercial standards composed of representatives from various national standards bodies.

ISO 9000:2000: The International Organization for Standardization models for quality assurance. ISO 900:2000 is the model for design, development, production, and installation and servicing.

ISO 13485:1996 and ISO 13488:1996 Standards: The International Organization for Standardization's particular requirements for suppliers of medical devices that is more specific than ISO 9001 and ISO 9002, respectively. ISO 13485 represents a model for quality assurance in design, development, production, installation and servicing. ISO 13488 covers all of the foregoing except design. ISO 13485 and ISO 13488 should be applied in conjunction with the ISO 9001:1994 and ISO 9002:1994, respectively. These are not stand-alone standards. The European version of ISO 13485 and ISO 13488 is EN ISO 13485 and EN ISO 13488 respectively.

ISO 13485:2003: ISO 13485:2003 Medical devices – Quality management systems:  Requirements for regulatory purposes replaces ISO 13485:1996 and ISO 13488:1996. This is a stand-alone standard, modelled on ISO 9001:2000, but does not require continual improvement or customer satisfaction.

Material safety data sheet (MSDS): Form containing data regarding the properties of a particular substance. An important component of workplace safety, it is intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner, and includes information such as physical data (melting point, boiling point, flash point, etc.), toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill handling procedures. The exact format of an MSDS can vary from source to source.

21 CFR Part 11: Section of the Code of Federal Regulations that deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11 as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries (not including food manufacturers) to implement controls, including audits, validation systems, and documentation for software and systems involved in processing many forms of data as part of business operations and product development.