DIRECTORY
Glossary
Accreditation
Procedure by which a recognized body formally confirms that a body or person is competent to perform certain tasks. DIN EN ISO/IEC 17025 describes the general requirements for the competence of testing and calibration laboratories.
Acid value
Indicates the amount of KOH in mg needed to neutralize the free fatty acids in one gram of fat.
AMG
Law on the Marketing of Medicinal Products (Medicinal Products Act – AMG)
AMWHV
Ordinance on the Application of Good Manufacturing Practice in the Production of Medicinal Products and Active Substances and on the Application of Good Professional Practice in the Production of Products of Human Origin
Antibiotics
Metabolic and growth inhibitors of microorganisms. Mostly effective or killing even in small quantities.
API
Active Pharmaceutical Ingredient for drug substance, active pharmaceutical ingredient
Audit, inspection
Systematic and independent examination to determine whether the quality-related activities and the related results comply with the specifications and whether these specifications are realized efficiently and are suitable to achieve the objectives.
BfArM
Federal Institute for Drugs and Medical Devices
BtMG
Law on the circulation of narcotics
CMR
Abbreviation for carcinogenic, mutagenic and toxic for reproduction. Designates substances with additional hazard potential. These are divided into three categories according to their dangerousness.
Coulometrie
Quantitative, electrochemical method for determining the amount of substance of oxidizable or reducible compounds. It is used, for example, to determine the water content according to Karl-Fischer.
Cytostatics
Toxic chemical substance that disrupts, delays or prevents the cell cycle. Mostly used in the therapy of tumor diseases.
DAB
German Pharmacopoeia
DAkkS
German Accreditation Body GmbH. National Accreditation Body of the FRG.
Dissolution
Determination of active ingredient release of various drug dosage forms using “leaf stirrer” or “rotating basket” apparatus. The methods are described in the pharmacopoeias (Ph. Eur. chapter 2.9, USP chapter 711).
Drying loss
Gravimetric method for determining the water content within a sample
Friability
Determination of the abrasion of tablets under stress
GC
Gas chromatography – Laboratory process for separating volatile chemical mixtures, e.g. plant constituents.
GMP
Good Manufacturing Practice, guidelines for quality assurance of the production processes and environment in the production of drugs and active ingredients.
Headspace
German: “Steam Room Analysis”. Here, the sample is not taken from the liquid phase but from the vapor space above and analyzed.
Hormones
Signaling and messenger molecules that serve to regulate various bodily functions.
HPLC
“High pressure (performance) liquid chromatography: Laboratory method for separating complex mixtures, which allows qualitative and quantitative statements to be made about the components.
ICH
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
In vitro release
s. Dissolution
Iodometry
Titrimetric analysis method based on the equilibrium reaction of iodide ions and iodine. This is applied, for example, in the determination of the water content according to Karl-Fischer.
Karl Fischer
Laboratory analytical method for the quantitative determination of water, e.g. for determining the water content of a drug.
LC-MS
Coupling of mass spectrometry with liquid chromatography (LC-MS)
Limit of detection (LOD)
Lowest amount of a substance that can still be detected but cannot be quantified
Limit of quantification (LOQ)
Lowest quantifiable amount of a substance
Narcotics (BTM)
Substances and preparations listed in Annex I to III of §1 par. 1 of the German Narcotics Act.
Opalescence
Colorfulness that results from the scattering of light by small structures within fabrics.
Peroxide number
Serves to assess the fat spoilage. The amount of peroxide-bound oxygen is determined titrimetrically (millimoles per kg of fat).
Pharmacopoeia
“published collection of recognized pharmaceutical rules concerning the quality, testing, storage, dispensing and designation of medicinal products and the substances used in their manufacture.” (§ 55 AMG)
Photometry
Measurement method within the UV-Vis range using a photometer (see UV/Vis spectroscopy).
Potentiometry
Electrochemical method for the quantitative determination of substances using the change in electrochemical potential when reagent solution is added.
Pycnometry
Gravimetric method for determining the density of solids and liquids
QA system
The defined process and organizational structure of quality management and the resources required for this.
QM Manual
Summarized description of the quality principles of a company and explanation of how the steering, controlling and monitoring means in the company work and thus the activities that have an influence on quality.
Qualification
Documented evidence that a room, system, or facility is suitable for its intended use.
Qualified Person
German “Qualified person”. Is responsible for the compliance with the regulations of the drug law as well as the complete documentation of the compliance with these regulations before placing a drug on the market.
Quality
The totality of properties and characteristics of a unit that relate to its suitability for meeting defined or assumed requirements or specifications.
Quality assurance
Is an umbrella term for approaches and measures to ensure and maintain defined quality requirements.
Quality management
Determination, implementation and control of quality issues in a company. Quality management is the aspect of the overall management task that defines and implements the quality policy.
Release Testing
Carrying out an investigation on the drug and/or its components, based on the result of which the drug is released, see also §16 AMWHV.
Stability test
Stability testing of a raw material or a drug product is used to experimentally determine its shelf life. This involves checking whether the raw material or drug product meets the defined specifications in terms of microbiological, physical and chemical properties over the storage period. For the storage of the drugs for stability testing, the storage conditions, i.e. temperature and relative humidity, are selected depending on the requirements specified by the climate zone(s).
Standard addition
Serves to minimize instrumental errors or is also used for samples with a high matrix load. Here, instead of using a calibration line, a specific amount of analyte is added.
Titration
Quantitative, volumetric method for determining the amount of substance via chemical reactions with a measured solution.
TLC
Thin-layer chromatography – Laboratory process for separating chemical mixtures, e.g., plant constituents.
Transfer plan
Described procedure within a method transfer.
UV/Vis spectroscopy
Measurement of the absorbance of solutions at different wavelengths in the UV and visible light range.
Validation
General: Documented evidence that a process, procedure, or analytical method is suitable for the intended use and produces the expected results.
With regard to the validation of a test method, this means providing evidence that a test method is suitable for fulfilling a given specific test task.
Verification
General: Confirmation based on an investigation and by providing evidence that specified requirements are met.
With regard to the verification of a test method, it is investigated whether it is suitable for solving the tasks that are common in a given test area or for fulfilling the requirements specified in a given area.