Glossary

DIRECTORY

Glossary

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.

Indicates the amount of KOH in mg needed to neutralize the free fatty acids in one gram of fat.

Law on the Marketing of Medicinal Products (Medicinal Products Act – AMG)

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

Metabolic and growth inhibitors of microorganisms. Mostly effective or killing even in small quantities.

Active Pharmaceutical Ingredient for drug substance, active pharmaceutical ingredient

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.

Federal Institute for Drugs and Medical Devices

Law on the circulation of narcotics

Abbreviation for carcinogenic, mutagenic and toxic for reproduction. Designates substances with additional hazard potential. These are divided into three categories according to their dangerousness.

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.

Toxic chemical substance that disrupts, delays or prevents the cell cycle. Mostly used in the therapy of tumor diseases.

German Pharmacopoeia

German Accreditation Body GmbH. National Accreditation Body of the FRG.

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).

Gravimetric method for determining the water content within a sample

Determination of the abrasion of tablets under stress

Gas chromatography – Laboratory process for separating volatile chemical mixtures, e.g. plant constituents.

Good Manufacturing Practice, guidelines for quality assurance of the production processes and environment in the production of drugs and active ingredients.

German: “Steam Room Analysis”. Here, the sample is not taken from the liquid phase but from the vapor space above and analyzed.

Signaling and messenger molecules that serve to regulate various bodily functions.

“High pressure (performance) liquid chromatography: Laboratory method for separating complex mixtures, which allows qualitative and quantitative statements to be made about the components.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

s. Dissolution

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.

Laboratory analytical method for the quantitative determination of water, e.g. for determining the water content of a drug.

Coupling of mass spectrometry with liquid chromatography (LC-MS)

Lowest amount of a substance that can still be detected but cannot be quantified

Lowest quantifiable amount of a substance

Substances and preparations listed in Annex I to III of §1 par. 1 of the German Narcotics Act.

Colorfulness that results from the scattering of light by small structures within fabrics.

Serves to assess the fat spoilage. The amount of peroxide-bound oxygen is determined titrimetrically (millimoles per kg of fat).

“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)

Measurement method within the UV-Vis range using a photometer (see UV/Vis spectroscopy).

Electrochemical method for the quantitative determination of substances using the change in electrochemical potential when reagent solution is added.

Gravimetric method for determining the density of solids and liquids

The defined process and organizational structure of quality management and the resources required for this.

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.

Documented evidence that a room, system, or facility is suitable for its intended use.

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.

The totality of properties and characteristics of a unit that relate to its suitability for meeting defined or assumed requirements or specifications.

Is an umbrella term for approaches and measures to ensure and maintain defined quality requirements.

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.

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 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).

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.

Quantitative, volumetric method for determining the amount of substance via chemical reactions with a measured solution.

Thin-layer chromatography – Laboratory process for separating chemical mixtures, e.g., plant constituents.

Described procedure within a method transfer.

Measurement of the absorbance of solutions at different wavelengths in the UV and visible light range.

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.

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.

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