More information about some of the technical and specialist terms and acronyms used on our site.
21 CFR Part 11 of the Code of Federal Regulations deals with the United States Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures. It defines the criteria under which electronic records and signature are considered to be untrustworthy, reliable and equivalent to paper records. Part 11 requires drug makers, medical device manufacturers, biotechnology companies, biologics developers, CRO’s, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.
Atomic Absorption Spectroscopy (AAS)
A technique for determining the concentration of a particular metal element in a sample. The technique can be used to analyse the concentration of over 70 different metals in a solution.
BS EN ISO/IEC 17025:2005
This standard specified the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods and laboratory-developed methods. It is applicable to all organisations performing tests and/or calibrations. It is used by laboratories in developing their management system for quality, administrative and technical operations.
This is a method of determining the concentration of a chemical element or compound in solution with the aid of a colour reagent. It is applicable to both organic compounds and inorganic compounds and may be used with or without an enzymatic stage.
Confocal Microscopy is an optical imaging technique used to increase optical resolution and contrast of a micrograph by adding a spatial pinhole placed at the confocal plane of the lens to eliminate out-of-focus light. It enables the reconstruction of three-dimensional structures from the obtained images.
Current Good Manufacturing Practice (cGMP)
Are the practices required in order to conform to guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of food, drug products, active pharmaceutical products and medical devices.
Deoxyribonucleic Acid (DNA)
Is a nucleic acid that contains the genetic instructions used in the development and functioning of all known living organisms and some viruses. The main role of DNA molecules is the long-term storage of information. DNA is often compared to a set of blueprints or a recipe, or a code, since it contains the instructions needed to construct other components of cells, such as proteins and RNA molecules. The DNA segments that carry this genetic information are called genes, but other DNA sequences have structural purposes, or are involved in regulating the use of this genetic information.
Differential Scanning Calorimetry (DSC)
Differential scanning calorimetry is a thermoanalytical technique in which the difference in the amount of heat required to increase the temperature of a sample and reference are measured as a function of temperature.
Electron Capture Detector (ECD)
This is a device for detecting atoms and molecules in a gas through the attachment of electrons via electron capture ionisation.
Electrophoresis is a separations technique based on the mobility of ions in an electric field. Positively charged ions migrate towards a negative electrode and negatively charged ions migrate to a positive electrode. Examples include gel electrophoresis, capillary electrophoresis.
Energy Dispersive X-ray (EDX)
An analytical technique used for the elemental analysis or chemical characterisation of a sample. It relies on an interaction of some source of x-ray excitation and a sample. Its characterisation capabilities are due to the fundamental principle that each element has a unique atomic structure allowing unique set of peaks on its x-ray spectrum.
Enzyme Linked Immunosorbent Assay (ELISA)
A biochemical technique used to detect the presence of an antibody or antigen in a sample.
European Food Safety Authority (EFSA)
An agency of the European Union that provides independent scientific advice and communication on existing and emerging risks associated with the food chain. The Authority's work covers all matters with a direct or indirect impact on food and feed safety, including animal health and welfare, plant protection, plant health and nutrition.
Evaporative Light Scattering Detector (ELSD)
Evaporative light scattering (ELS) detection works by nebulising the solvent flow from a liquid chromatography system and entraining the resultant droplets in a gas stream. The mobile phase is then evaporated from the droplets. When an analyte is less volatile hen the mobile phase, it remains in the gas stream as a "dry" solute particle and flows to the ELS detector. Once there, the particles scatter the light beam. The amount of scattered light is measured and bears a relationship to the concentration of material eluting.
This is a food chemistry proficiency testing programme - Food Analysis Performance Assessment. Tests available include the following analytes in food, feed and drink: nutritional components, food ingredients, natural food contaminants, organic and inorganic contaminants, pesticides, veterinary drug residues, food additives, migration from food packaging, allergens and authenticity.
Flame Ionisation Detector (FID)
The operation of the FID is based on the detection of ions formed during combustion of organic compounds in a hydrogen flame. The generation of these ions is proportional to the concentration of organic species in the sample gas stream.
Fluorescence Detector (FD)
Fluorescence occurs when certain molecules absorb light at specific wavelengths, promoting the molecules to a higher energy state. As they return to their normal energy states, the "excited" molecules release their absorbed energy as photons. Fluorescence detection requires both the excitation/emission wavelengths, leading to a higher degree of sensitivity.
Food and Drink Administration (FDA)
An agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.
Food Standards Agency (FSA)
A non-ministerial government department, responsible for protecting public health in relation to food throughout the United Kingdom and is led by an appointed board that is intended to act in the public interest
Fourier Transform Infrared Spectroscopy (FT-IR)
A measurement technique whereby spectra are collected based on measurements of the temporal coherence of a radiative source, using time-domain measurements of the electromagnetic radiation or other type of radiation.
Gas Chromatography (GC)
Gas chromatography is an analytical chemistry technique used for separating and analysing compounds that can be vaporised without decomposition. In GC, the mobile phase is a carrier gas, usually an inert gas such as helium or an unreactive gas such as nitrogen. The stationary phase is a microscopic layer of liquid or polymer on an inert solid support in a column. The gaseous compounds being analysed interact with the stationary phase. This causes each compound to elute at different times, the comparison of retention times is what gives the technique its analytical usefulness.
Gas Chromatography Mass Spectroscopy (GC-MS)
An analytical method that combines the features of gas-liquid chromatography and mass spectrometry to identify different substances within a test sample.
Gas Chromatography - Time-of-Flight Mass Spectrometry (GC-TOFMS)
Time-of-flight mass spectrometry is a method of in which an ion’s mass-to-charge ratio is determined via time measurement. Ions are accelerated by an electric field of known strength. This acceleration results in an ion having the same kinetic energy of any other ion that has the same charge. The velocity of an ion depends on the mass-to-charge ratio. The time that it takes for the particle to reach a detector at a known distance is measured. This time will depend on a mass-to-charge ratio of the particle (heavier particles reach lower speeds). From this time and the known experimental parameters, you can find the mass-to-charge ratio of the ion.
Gas Chromatography-Olfactometry (GC-O)
This technique couples traditional gas chromatographic analysis with sensory detection in order to study complex mixtures to identify odour active compounds.
Gel Permeation Chromatography (GPC)
This is a type of size exclusion chromatography that separates based on the size or hydrodynamic volume of analytes. Separation occurs via the use of porous beads packed into a column (stationary phase). The smaller analytes can enter the pores more easily and are therefore retained for longer, increasing their retention time. Conversely, larger analytes are not retained are eluted quickly.
This is a proficiency testing scheme for the testing of genetically modified soya and maize administered by FERA - Genetically Modified Materials Analysis Scheme.
Refers to the process of determining the genotype of an individual by the use of biological assays.
Good Distribution Practice (GDP)
Good distribution practice deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality system which includes requirement for purchase, receiving, storage and export of drugs intended for human consumption.
A set of methods in analytical chemistry for the quantitative determination of an analyte based on the mass of a solid.
Hazard Analysis Critical Control Point (HACCP)
A food safety management system based on the principles of HACCP using a systematic approach to identifying and controlling hazards, whether microbiological, chemical or physical, that could pose a threat to the production of safe food. In simple terms, it involved identifying what could go wrong in a food system and planning how to prevent it.
High Pressure Liquid Chromatography (HPLC)
Is a form of column chromatography used frequently in biochemistry and analytical chemistry to separate, identify, and quantify compounds.
Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
ICP-MS is a type of mass spectrometry that is highly sensitive and capable of the determination of a range of metals and several non-metals at low concentrations. It is based on coupling together inductively coupled plasma as a method of producing ions (ionization) with a mass spectrometer as a method of separating and detecting the ions.
Inductively Coupled Optical Emission Spectroscopy (ICP-OES)
An analytical technique used for the detection of trace metals. It is a type of emission spectroscopy that used the inductively coupled plasma to produce excited atoms and ions that emit electromagnetic radiation at wavelengths characteristic of a particular element. The intensity of this emission is indicative of the concentration of the element within the sample.
A technique that allows the separation of ions and polar molecules based on their affinity to the ion exchanger. It can be used for almost any kind of charged molecule including large proteins, small nucleotides and amino acids. Ion exchange chromatography retains analyte molecules on the column based on coulombic (ionic) interactions. The stationary phase surface displays ionic functional groups that interact with analyte ions of opposite charge. This type of chromatography is further subdivided into cation exchange chromatography and anion exchange chromatography.
This is the International Register of Certified Auditors which is the leading professional body for management system auditors.
Is a classic titration method in analytical chemistry that uses colorimetric or volumetric titration to determine trace amounts of water in a sample.
This uses an optical instrument containing one or more lenses that produces an enlarged image of a sample in the focal plane. Optical microscopes have refractive glass, to focus light into the eye or another light detector. Typical magnification, assuming visible range light, is up to 1250x with a theoretical resolution limit of around 0.250 µm or 250 nm. This limits the practical magnification limit to ~1500x.
This is a technique that is used to separate mixtures. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material called the stationary phase. The constituents of the mixture travel at different speeds, causing them to separate. The separation is based on differential partitioning between the mobile and stationary phases. Differences in a compound's partition coefficient result in differential retention on the stationary phase and thus changing the separation.
Liquid Chromatography Mass Spectrometry (LC-MS)
Is an analytical chemistry technique that combines the physical separation capabilities of liquid chromatography (or HPLC) with the mass analysis capabilities of mass spectrometry. LC-MS is a powerful technique used for many applications which has very high sensitivity and specificity. Generally its application is oriented towards the specific detection and potential identification of chemicals in the presence of other chemicals (in a complex mixture).
Medicines and Healthcare Regulatory Agency (MHRA)
The MHRA is a UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
Membrane Assisted Solvent Extraction (MASE)
Membrane-assisted solvent extraction is based on small-scale liquid-liquid extraction with a flat, low density polyethylene (LDPE) membrane separating an aqueous sample from an organic solvent.
Nuclear Magnetic Resonance (NMR)
Is the name given to a physical resonance phenomenon involving the observation of specific quantum mechanical magnetic properties of an atomic nucleus in the presence of an applied, external magnetic field. Many scientific techniques exploit NMR phenomena to study molecular physics, crystals and non-crystalline materials through NMR spectroscopy.
A pharmacopoeia is a legally binding collection of standards and quality specifications for medicines used in a country or region. Within the pharmacopoeia, a quality specification is a set of appropriate tests that will confirm the identity and purity of the product, ascertain the strength (or amount) of the active substance and, when needed the performance characteristics. Reference substances are used in testing to help ensure the quality, such as identity, strength and purity of medicines. A pharmacopoeia also covers pharmaceutical starting materials, excipients, intermediates and finished products. General requirements may also be given on important subjects related to medicine quality, such as analytical methods, microbiological purity, dissolution testing, or stability. The role of the modern pharmacopoeia is to furnish quality specifications for active pharmaceutical ingredients, finished pharmaceutical products and general requirements.
BP - British Pharmacopoeia
EP - European Pharmacopoeia
JP - Japanese Pharmacopoeia
USP - United States Pharmacopoeia
Polymerase Chain Reaction (PCR)
A technique widely used in molecular biology. It derives its name from one of its key components, a DNA polymerase used to amplify a piece of DNA. As PCR progresses, the DNA generated is used as a template for replication. It is possible to amplify a single piece of DNA generating many copies.
Proton Transfer Reaction - Mass Spectrometry (PTR-MS)
PTR-MS is a very sensitive technique for the analysis of volatile organic compounds. The instrument consists of an ion source that is directly connected to a drift tube and a quadrupole or time-of-flight mass spectrometer.
Qualified Person (QP)
Qualified Person (QP) is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal Products for Human Use). The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements.
Real-time Polymerase Chain Reaction (RT-PCR)
Real-time PCR is a technique used to amplify and detect or quantify a targeted DNA molecule. The procedure follows the general principle of PCR; its key feature is that the amplified DNA is detected as the reaction progresses in "real-time".
Refractive Index Detector (RI)
This is a detector consisting of a light source, a hollow prism and a photoelectric cell that is used to detect non-ultraviolet-absorbing molecules in a sample separated by chromatography. Light from the sample passes through a flow cell with two channels towards the photoelectric cell. One channel holds the eluent from the column, whereas the other holds the control sample (solvent that has not passed through the column). Detection occurs when the light is bent due to molecules eluting from the column, and this is read as a disparity between the two channels.
Responsible Person (RP)
The Human Medicines Regulations require a distributor to designate a Responsible Person(s) (RP), named on the applicable licence. Regulation 45 and the EU GDP Guide set out the requirements and the responsibilities.
The study of the flow of matter: mainly liquids but also soft solids or solids under conditions in which they flow rather than deform elastically. It applies to substances which have a complex structure including suspensions, polymers, many foods and other biological materials.
Royal Society for Public Health (RSPH)
The Royal Society for Public Health is an independent, multi-disciplinary charity, dedicated to the promotion and protection of collective human health and wellbeing.
Scanning Electron Microscopy (SEM)
Is a type of electron microscope that images the sample surface by scanning it with a high-energy beam of electrons in a raster scan pattern. The electrons interact with the atoms that make up the sample producing signals that contain information about the sample's surface topography, composition and other properties such as electrical conductivity.
Thermogravimetric Analysis (TGA)
This is a method of thermal analysis in which changes in physical and chemical properties of materials are measure as a function of increasing temperature (with contact heating rate), or as a function of time (with constant temperature and/or constant mass loss). TGA can provide information about physical phenomena, such as second-order phase transitions, including vaporisation, sublimation, absorption, adsorption and desorption. Likewise, TGA can provide information about chemical phenomena including chemisorptions, deslovation (especially dehydration), decomposition, and solid-gas reactions (for example, oxidation or reduction).
This is a method of quantitative analysis based on the measurement of the volume of solution with a precisely known concentration of a reagent (the titrant) required for reaction with a given amount of substance being determined (the analyte). Among the means used in titrimetric analysis are complexing and precipitation, acid-base, and oxidation-reduction reactions. The main requirements for the reactions used in titrimetric analysis are high speed, the presence of stoichiometric proportions, and the absence of side reactions.
United Kingdom Accreditation Service (UKAS)
UKAS is the sole national accreditation body recognised by government to assess, against internationally agreed standards, organisations that provide certification, testing, inspection and calibration services.
This is a technology that uses computer-processes x-rays to produce tomographic images (virtual "slices") of specific areas of the scanned object, allowing the user to see what is inside it without cutting it open. Digital geometry processing is used to generate a three-dimensional image of the inside of an object from a large series of two-dimensional radiographic images taken around a single axis of rotation.