Pharmaceutical terms and definitions
German Medicines Act (AMG) drug law
Law on the marketing of medicinal products, defines the term medicinal product and the requirements for its quality, efficacy and safety. It contains regulations on manufacture, labelling, clinical testing, marketing authorisation, monitoring of drug risks and side effects.
Collection of recognised rules on the quality, manufacture, testing, storage, dispensing and designation of medicinal products, usually at national level, e.g. German Pharmacopoeia 10 (exceptions: European Pharmacopoeia, Nordic Pharmacopoeia, RGW Pharmacopoeia).
Audit (quality audit) audit
Review of some or all of the steps involved in a manufacturing process or in the manufacture, storage and quality control of a specific product; carried out by internal or external bodies (e.g. licensors, regulatory authorities).
Any substance used in the manufacture of a medicinal product or active substance, excluding packaging material (see also manufacturing formula).
Microorganisms without a true cell nucleus that can multiply very rapidly by division under favorable conditions (moisture, nutrients) (e.g. Escherichia coli).
Usually a printed sequence of various thick, machine-readable bars whose arrangement uniquely characterizes an object (= bar code), e.g. on folding boxes, instructions for use, labels.
Operating Ordinance for Pharmaceutical Companies
(PharmBetrVO = Pharmaceutical Operations Ordinance)
Legal regulation for the implementation of the basic rules of the WHO and the EU for the manufacture of medicinal products and the assurance of their quality as well as the basic rules of the Pharmaceutical Inspection Convention (PIC); it applies to companies and facilities that manufacture, test, store or market medicinal products on a commercial basis.
Bulk goods bulk
Bulk goods are medicinal products in large containers from which they are filled and packed into packages intended for distribution to the end user (e.g. ampoules filled but not yet finally packed, loose tablets in a container, etc.).
The quantity of a product manufactured in a uniform manufacturing process; it must be homogeneous, i.e. evenly composed, and manufactured under the same conditions.
Batch designation (Ch.-B.) batch no.
Unique marking of each manufactured batch, e.g. by means of a combination of numbers or letters, by means of which identification and unambiguous tracing of the finished medicinal product to the raw materials used is possible.
Cleaning-In-Place (CIP) CIP
Cleaning system installed in production facilities to ensure reproducible and documented cleaning processes.
Cross contamination cross contamination
Contamination of a material (raw material, product) with another material that was previously used on the same line or simultaneously on a neighboring line, e.g. through transfer of dust or mixing.
Steam sterilization steam sterilization
Killing of microorganisms and spores by treatment with superheated steam, usually for 20 min at 125 °C.
Form of the drug that is adapted to the route of administration and desired release of the active ingredient, e.g. injection solution, film-coated tablet, hard gelatine capsule, etc..
Prolonged release dosage form
A prolonged release dosage form of a drug ensures that the active ingredient is released as evenly as possible from an active ingredient supply over a certain period of time; this means that, for example, a multiple dose per day can be replaced by a single dose.
Killing or inactivation of microorganisms with the aid of chemical disinfectants.
Substances used to kill or inhibit the growth of microorganisms, e.g. Sterilium, Bodecid, hydrogen peroxide solution.
Distilled water distilled water
Water that has been purified by distillation (evaporation/condensation); for comparison, see water for injection.
Fever-inducing substances (lipopolysaccharides) on the cell walls of gram-negative bacteria.
Deionized water deionized water
Water from which the dissolved salts (e.g. lime) have been removed, e.g. by ion exchange systems.
Inactivation of pyrogens, e.g. by strong heating (ampoules, infusion bottles), ultrafiltration (solutions) or chemical treatment with hydrogen peroxide or caustic soda.
See Deionised water.
Finished drugs are medicines that are manufactured in advance (usually industrially) rather than being made individually by the pharmacist in the pharmacy. Finished drugs are marketed in a package intended for distribution to the consumer.
The study of medicinal products and their preparation.
Substances or products that are hazardous to health, e.g. because they are corrosive, irritant, explosive, etc.
Purified water purified water
Is produced from drinking water by ion exchange (deionized water) and subsequent counter-osmosis (to remove all dissolved constituents) and is required for the production of pharmaceuticals with the exception of parenterals (see water for injections).
GCP (Good Clinical Practice)
Guideline for the organizational procedure of clinical trials as well as their evaluation and documentation.
GLP (Good Laboratory Practice)
Guideline on the organizational procedure and the conditions under which laboratory tests (toxicology, safety tests) are planned, carried out and monitored, as well as with the recording and reporting (documentation) of the tests. The GLP guidelines are part of the Chemicals Act.
GMP (Good Manufacturing Practice)
Guidelines for the manufacture, quality control and quality assurance of medicinal products; they require compliance with recognized rules regarding raw material quality, manufacturing facilities and buildings, production processes, in-process controls, inspections, hygiene, documentation and distribution, etc.. They are issued by national (e.g. U.S.A.-FDA) and international bodies (WHO, EU).
Internal term for intermediate products, i.e. partially processed drugs that still have to pass through further production stages (usually packaging, see also bulk, material number).
Hot air sterilization dry heat sterilization
Killing of microorganisms and spores by dry heat, e.g. to 121 °C for 15 minutes.
Manufacturing report batch record
Summarized documentation of the manufacture of a specific batch of a product consisting of bill of material, manufacturing instruction with entered and signed measured values, process assurance certificate, results sheet, etc.
Manufacturing formula batch formula
The manufacturing formula is part of the manufacturing specification and defines the starting materials required to manufacture a product in terms of quality and quantity.
All activities associated with the manufacture of a drug product, including procurement of starting materials, processing, mixing, formulation, filling, packaging, labeling, quality control, and storage.
Detailed work instructions for the manufacturing personnel for the production of a batch of a specific product.
The production manager is responsible for ensuring that the medicinal products are manufactured, stored and labelled in accordance with the regulations and that they are provided with the prescribed package insert. The production manager is confirmed by the responsible authority (regional council).
Manufacturing specification master production record
The composition, the manufacturing formula, the manufacturing process with in-process controls, and the packaging are described in a master batch record for a specific drug; the manufacturing manager is responsible for creating these master batch records. Production instructions are usually intended for the information of authorities and license partners.
Non-pharmaceutically active ingredient of a medicinal product.
See hot air sterilization.
Hygiene plan sanitation program
Compilation of all facilities and measures which serve to protect drugs from contamination and germs, e.g. clean rooms, sluices, clean room clothing, cleaning, disinfection, etc..
Infusion solution infusion
Infusion solutions are sterile, mostly isotonic aqueous solutions. They are low in endotoxins and are generally intended to be administered in large quantities (up to litres). This is usually done intravenously (into the bloodstream).
Sterile solution, emulsion or suspension administered by syringe (volume up to approx. 100ml) which must be low in endotoxin from 15ml volume; aqueous solutions are usually isotonic.
In-process control (IPC) inprocess control
Controls during production to monitor and, if necessary, control the process to ensure that the product meets specifications.
Determination and documentation of the difference between the displayed and actual value of a measuring device (if too large, adjustment follows).
CFU (= colony forming units) cfu
Number of reproducible germs per unit of area or volume (determined, for example, by means of swab samples).
Obsolete term for microorganisms capable of reproduction.
Germ count reduction reduction of cfu
Reduction in the number of germs in rooms, systems or products, e.g. by disinfection, filtration, heat treatment or sterilization.
Systematic investigation of patients and volunteers (who do not suffer from the disease for which the drug is intended) with the aim of discovering or confirming pharmacodynamics, therapeutic effects and/or undesirable side effects of an investigational drug; in addition, investigations of absorption, distribution, metabolism and excretion of an active substance in order to ensure the efficacy and safety of a drug.
Packaging of semi-finished or bulk products into finished medicinal products.
The fulfilment of defined requirements (specifications).
Substances which are usually added in low concentrations, e.g. to medicines, and are intended to prevent germ growth.
Control manager quality control manager
The control manager of a pharmaceutical company is responsible for ensuring that only medicinal products that have previously been tested for the required quality and approved are placed on the market. The control manager is confirmed by the responsible authority (regional council).
Laminar Flow (LF) LF
Uniform, i.e. non-turbulent air flow with a constant velocity of 0.3 - 0.5 m/sec. Certain working areas (filling of sterile products, microbiological laboratories, etc.) are protected against the ingress of particles and micro-organisms by an air flow previously filtered by means of a HEPA filter under laminar flow conditions.
The period of time during which a drug is stable after manufacture and may be placed on the market (must be documented by stability testing).
Contract manufacture Contract manufacture
Performance of a complete manufacture or parts of the manufacture of a medicinal product at another pharmaceutical company. The contractor is also subject to the pharmaceutical company regulation; the responsibility for correct manufacture and quality is always borne by the client. The distribution of tasks is regulated by a contractual agreement on contract manufacturing (Contract Manufacturing Agreement), and the exact responsibilities with regard to manufacturing and quality control, including the definition of qualities, quantities, methods, etc., are regulated by a supplementary agreement (Quality Agreement).
Material number material no.
Unique number to identify all materials used for the production of active ingredients or drugs, such as raw materials, intermediates, active ingredients, excipients, bulk materials, packaging materials, and finished drugs; it defines properties and quality:
- Purchased raw materials for production
- Semi-finished goods (from chemical/pharmaceutical production)
- Packaging materials
- Finished medicinal products (for sale) or bulk goods (for dispatch)
- Finished medicinal products (samples)
- Starting materials for galenic development
Collective term for microorganisms, e.g. bacteria, unicellular fungi (molds, yeasts).
Continuous monitoring of processes and procedures with reporting with the aim of identifying the causes of non-accidental deviations in good time and being able to take countermeasures. E.g. particles or germs in the manufacturing and filling area
(= microbiological monitoring).
Oralia oral drugs
Drugs to be taken by mouth.
Materials used to package medicinal products, e.g. bottles, rubber stoppers, labels, films, folding boxes, etc.
Packaging materials packaging material
Materials from which packaging materials are made, e.g. glass, polyethylene, cardboard, aluminum, paper, etc.
Properties of microorganisms to cause diseases in humans and animals under certain conditions after ingestion or penetration into the body.
Unit of measurement (negative decadic logarithm) for the concentration of hydrogen ions, indicates the acidity of acids or the basicity of alkalis (pH 1: strongly acidic, pH 7: neutral, pH 14: strongly basic).
Pharmaceutical Inspections Convention (PIC)
Agreement between a number of industrial nations for the mutual recognition of regulatory inspections (audits).
Class of organisms (with a true cell nucleus) living on organic material in the form of dead or living plants or animal organisms; important as a pathogen (mould), supplier of medicinal substances (penicillin) or for food production (baker's yeast, brewer's yeast).
Primary packaging material
Parts of the packaging of a drug that come into contact with the product, such as ampoules, blister foils, rubber stoppers, etc.
Test instruction analytical procedure
Written instruction for testing or analyzing a drug or its starting materials; contains information on the name and dosage form, the quality requirements (specifications), the procedure and scope of sampling and testing, and the period of validity.
The determination (measuring, examining, measuring) of one or more characteristics of a unit (product, activity, process, etc.) and subsequent comparison with defined requirements (specifications) to determine whether conformity (conformity) has been achieved for each characteristic.
Formal and systematic proof of the functional capability and suitability of a system or measuring equipment for the intended purpose.
A distinction is made between:
- Qualification after installation (installational qualification = IQ)
- Qualification during operation (operational qualification = OQ)
The totality of characteristics of a unit (product, activity, process, etc.) with regard to its suitability to fulfil defined and presupposed requirements. In pharmaceutics, the nature of a medicinal product as determined by its identity, purity, chemical, biological and physical properties and by the manufacturing process, and assessed on the basis of its conformity with predefined specifications.
Quality control quality control
The sum of all measures, including tests or measurements on samples, to demonstrate that a batch of a raw material or product is homogeneous and meets established specifications for content, purity and other properties.
Quality costs (quality-related costs) quality costs
Costs incurred as a result of quality requirements consist of costs incurred through defect prevention activities, through scheduled quality inspections, and in the event of non-achievement of quality (losses, destruction, recourse).
Quality management quality management
Sum of all activities of the overall management task of a company, which define the quality policy, objectives and responsibilities as well as realize these through means such as quality planning, quality control, quality assurance and quality improvement within the framework of the quality management system.
Quality management system quality management system
Organizational structure, responsibilities, procedures, processes and the means necessary to achieve quality management.
System for defining, ensuring and regulating all quality-determining elements and activities, e.g. in development, planning, raw material procurement, production, quality control, building equipment, facilities with maintenance, etc. in accordance with legal and internal requirements.
Room disinfection romm disinfection
Disinfection of a production room by spraying or wiping with a suitable disinfectant after thorough cleaning.
See clean rooms/clean zones.
Clean rooms/clean zones clean rooms
Rooms or areas required in the manufacture of medicinal products with graded requirements for air quality and equipment defined by national and international authorities and associations (EU, PIC, FDA, etc.), which must be separated from each other by airlocks.
Clean room garments clean room garments
Work clothing suitable for use during production, filling and microbiological testing in clean rooms (sterile, non-particle releasing, covering free skin surface).
Slow-release formulations substained release formulations
Medicinal products which, because of their special composition, release the active substance more slowly in order to achieve a long-lasting or uniform pharmacological effect.
Documented origin of starting materials or parts; processing history, distribution of the product after its delivery
Reference of calibration to national/international norms, standards, physical constants, reference standards, etc.
Spaces between different cleanliness zones in which employees change according to the hygiene program for the respective other zone, or through which material is fed in or out.
Secondary packaging material outer packaging material
External parts of the packaging that do not come into contact with the product, such as folding cartons.
SOP (Standard Operating Procedure)
Written instructions that generally describe and bindingly define the execution of certain recurring processes and activities.
Qualitatively and quantitatively defined requirements for the characteristics of a unit (starting material, intermediate product, active substance, drug, technical equipment, measuring device, etc.).
Cells of micro-organisms (e.g. permanent forms of fungi, bacteria) which can withstand heating to 75 °C for 20 minutes.
Sterile filtration sterile filtration
Complete removal of germs capable of reproduction from solutions by means of filtration through membranes with a pore size < 0.2 µm (= 0.0002 mm).
Complete destruction of viable microorganisms by one of the valid sterilization methods, e.g. steam sterilization, heat sterilization, radiation sterilization, sterile filtration.
Automatic sterilization system installed in production facilities to ensure reproducible and documented sterilization processes, e.g. with steam.
Radiation sterilization sterilization by irradiation
Radiation sterilization is the killing of microorganisms and traces by gamma rays of certain energy.
Bar code barcode
Bill of material master production formula
List of all materials with material number, description, and quantity required to manufacture a batch of a particular product (active ingredient, semi-finished product, finished drug).
Reprocessing or correction of a batch of unsatisfactory quality (or parts thereof) with the aim of achieving the required quality in one or more operations, starting from a specific production stage.
Reverse osmosis (counter osmosis)reverse osmosis
Method for obtaining water of high purity; in this process, water is forced under high pressure through a semi-permeable membrane, whereby dissolved substances (molecules, ions) are largely retained; if water that has already been desalinated is used, "purified water" can be produced by means of e.g. two-stage reverse osmosis.
Written formal and systematic proof that a manufacturing process or an analytical method, when adhering to the specified conditions, meets the specified requirements and always leads to a product of the same quality or result of the same accuracy and reliability.
The time until which the content, efficacy or other quality-determining, specified properties of a batch of medicinal products (or a raw material, packaging material, etc.) are still guaranteed on the basis of the results of the stability tests.
Packaging form Packaging form
Type of primary packaging of a drug, e.g. ampoules, vials, blisters, etc.
Very small organisms, partly consisting only of nucleic acids and proteins, without metabolism of their own, need living cells as hosts to multiply, often act as pathogens (influenza, AIDS).
Water for injection water for injection
Highly pure water obtained from purified water, usually by distillation, which is free of microorganisms and endotoxins; it is used for the production of parenterals.
Substance from which a medicinally active component of a drug is derived.
Permission to market a finished drug, granted to the manufacturer after examination of the documentation by the Institute for Drugs and Medical Devices, in the case of vaccines by the Paul Ehrlich Institute after an examination procedure (in the case of foreign countries of the local branches/representation of the manufacturer by an appropriate authority).
Composition according to the marketing authorisation:
Type and quantity of active and non-active ingredients declared for a dose of a medicinal product (part of the marketing authorisation).
Composition according to manufacture:
Type and quantity of starting materials used for the manufacture of a drug dose (including necessary production and stability supplements).
Source: Pharmaceutical terms