Definitionen deutsch:

Definitionen englisch:

Anerkennungs-Kriterium

Gesetz

- aktiver Bestandteil

Aktiver pharmazeutischer Bestandteil (Wirkstoff)

- aktuelle Ausbeute

- unter Abweichung hergestellte Substanz

United States Food and Drug Administration. (FDA)

- Behörde

The process by which it is established, by laboratory studies, that the performance characteristics of the method meet the requirement for the intended analytical application.

- Analytische Validierungsmethode

A material used in the production of an API which is incorporated as a significant structural fragment into the structure of the API. A starting material may be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or it may be produced in-house. Starting materials are normally of defined chemical properties and structure.

- Wirkstoff-Ausgangsmaterial

An environment which is free from pathogenic microorganisms.

- steril

means a specific quantity of drug substance or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

Charge

A specific quantity of material produced in a process or series of processes so that its expected to be homogeneous within specified limits. In the case of continuous production a batch may correspond to a defined fraction of the production, characterised by its intended homogeneity. The batch size may be defined either by a fixed quantity or the amount produced in a fixed time interval.

Charge

A distinctive combination of numbers and/or letters which specifically identify a batch or lot and from which the production history can be determined.

Chargen-Bezeichnung

A unique combination of numbers and/or letters which specifically identify a batch or lot and from which the production and distribution history can be determined.

Chargen-Bezeichnung

Documentation that provides the history of a batch from the raw material stage to completion of the lot/batch.

Chargen-Dokument

means a material originating from a biological manufacturing process intended to be used in the manufacture of a medicinal product which provides the therapeutic activity of a medicinal product or other direct effect in the diagnosis of a disease.

aktiver biologischer, pharmazeutischer Bestandteil

Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention., treatment, or cure of diseases or conditions of human beings.

biologisches Produkt

Intermingling different conforming grades into a homogeneous lot.

Mischung

Materials (both pharmacologically active and inactive) which are intended for use as a component of a drug or biological product. These include materials manufactured by processes such as: (1) chemical synthesis; (2) fermentation; (3) recombinant DNA or other biotechnology methods; (4) isolation/recovery from natural sources, or (5) any combination of these processes.

pharmazeutische Bulkware (Massenware)

means any substance produced by chemical synthesis, fermentation, recombinant DNA processes or recovery from natural materials which is intended for use as a component in a drug product or a substance which is repackaged or labeled for drug use.

Bulkware (Wirkstoff)

Bulk Pharmaceutical Chemical (BPC)

Active Ingredient

Bulk Pharmaceutical Chemical (BPC)
Any active ingredient used in the manufacture of the dosage form of a drug.

Bulkware (Wirkstoff)

Excipient

The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements.

Kalibrierung

A document relating specially to the results of testing a representative sample drawn from the material to be delivered.

Analysen-Zertifikat

A process that involves a chemical transformation of a starting material or intermediate to form a new compound (e.g., bond formation, oxidation, reduction)

Chemische Reaktion

An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation and retention of contaminants in the area.

Reine Zone / Bereich

Any material used to clean process equipment , utensils, and storage vessels. These may include soaps, detergents, surfactants, alkalis, acids, or other materials, such as organic solvents, if the solvent is specially used for cleaning and is not a solvent used in the next processing step.

Reinigungsmittel

The blending of trace carryover material from one grade of an excipient with another usually due to a continuous process.

Zusammenmischen

means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.

Komponente

A group of hardware components and associated software, designed and assembled to perform a specific function or group of functions.

Computersystem

A process or operation integrated with a computer system.

computerisiertes System

A subset of prospective validation in which API batches are released for distribution, based on extensive testing, before completion of process validation. Once data from additional batches produced under replicated conditions show uniformity, the process may be considered validated.

begleitende Validierung

Achieving a level of control over a raw material, intermediate, or API that provides proper protection of these materials from external contamination and cross-contamination.

Eingrenzung, Kontrolle

An impurity not intended to be present in an excipient that may be introduced through such things as poor cleaning, processing, lack of appropriate environmental and personnel controls during the manufacturing process.

Kontaminante

Verunreinigung

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.

Kontaminierung

Verunreinigung

A process in which a material is continuously produced in a step or series of steps. In a continuous process, the batches of raw materials and the process parameters can be statistically, but not absolutely, correlated to the material produced in a given period of time.

fortlaufende Produktion

batch

A material, process step or process condition, test requirement or any other relevant parameter is considered to be critical when non-compliance with predetermined criteria directly influences the quality attributes of the API in a detrimental manner.

kritisch

means any instrument associated with the manufacturing, storage, or testing of material which can directly impact the attributes and/or quality of the material.

kritisches Gerät

A manufacturing process step which may cause variation in quality attributes.

kritischer Verfahrensschritt

Process parameter that must be controlled within established operating ranges to ensure that the API or intermediate will meet specifications for quality and purity.

kritischer Verfahrens-Parameter

Production steps that must be controlled to ensure that the intermediate or API will meet specifications for identity, strength, quality and purity

kritischer Verfahrensschritt

Contamination of a material or product with another material or product.

Kreuzkontamination

means a report that summarizes the major stages of the drug substance development from early stages through largescale manufacturing.

Entwicklungs-Bericht

As defined as section 201 (g)(1) of the act means (a) articles that are , in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National formulary, or any supplement to them; (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; and articles (other than food) intended to affect the structure or any function of the body of humans or other animals.

Arzneimittel

Detailed information concerning a specific facility, process or product submitted to the United States Food and Drug Administration intended for incorporation by reference into a new drug application, abbreviated new drug application, or investigational a new drug application.

Arzneimittel-Masterakte

A finished dosage form, for example, a tablet, capsule or solution, that contains an active pharmaceutical ingredient, generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an API but is intended to be used as a placebo.

Fertigarzneimittel

The dosage form in the final immediate packaging intended for marketing.

Fertigarzneimittel

or Active Pharmaceutical Ingredient (API)

Arzneimittelsubstanz (Wirkstoff)

Establishing confidence that process equipment and ancillary systems can consistently operate within established limits and tolerances.

geeignete Ausrüstung

Excipients are any substances other than the active drug or product which have been appropriately evaluated for safety and are included in a drug delivery system to either aid the processing of the drug delivery system during its manufacture, protect, support or enhance stability, bioavailability, or patient acceptability, assist in product identification, or enhance any other attribute of the overall safety and effectiveness of the drug delivery system during storage or use.

pharmazeutischer Hilfsstoff

The quantity of material or the percentage yield anticipated at any appropriate phase of production based on the historical data of process.

erwartete Ausbeute

The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf- life specifications if stored under defined con-ditions, and after which it should not be used.

Verfallsdatum

An impurity arising from any source extraneous to the manufacturing process.

Fremdsubstanz

means any particulate contaminant with a length at least three times greater than its width.

Faser

The last compound from which the Active Ingredient is produced. In the case of organic compounds this means a change in at least one covalent bond whilst for inorganic compounds this may mean a change in an ionic bond. The final intermediate is thus a starting material for the process step which produces the Active Ingredient.

letztes Zwischenprodukt

The purification and subsequent process steps to give the pure Active Ingredient and, if necessary, the further steps to produce the final Active Ingredient.

letzte Produktionsphase

A finished pharmaceutical product containing excipients and the active and the active drug substance which has been prepared for consumer applications.

Fertigarzneimittel

Any pharmaceutical product which has undergone all stages of production, including packaging and labeling.

Fertigprodukt

Any material which has undergone all stages of production and is released from quality control.

Means labeling derived from a sheet of material on which more than one item of labeling is printed.

Good Manufacturing Practices.

Material of uniform consistency and composition through a batch.

Homogenes Material

Any component other than an active ingredient.

Checks performed during production in order to monitor and if necessary to adjust the process and/or to ensure that the intermediate or API conforms to its specification.

Verfahrenskontrolle

Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the API conforms to its specification. The control of the environment or equipment may also be regarded as a part of in-process control.

Inprozesskontrolle

means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.

Zwischenprodukt, Reaktionsgemisch

Monitoring checks performed during production to ensure that the product conforms to its specifications.

Inprozesskontrolle

A material produced during steps of the processing of an API which must undergo further molecular change purification before it becomes an API.

Zwischenprodukt

A material produced during a manufacturing process that must undergo further molecular change or processing before it becomes an API or a biological API. Types of intermediates include:

Material which must undergo further manufacturing steps before it becomes a bulk product

Zwischenprodukt

means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a material produced by continuous process, a specific identified amount or the quantity produced in a unit of time or quantity in a manner that assures uniform character and quality within specified limits.

Charge

see batch

Charge

means any distinctive combination of letters, numbers, or symbols or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug substance or other material can be determined.

Chargennummer

All operations of purchase of materials, production, quality control, release, storage, and distribution of APIs and the related controls.

Herstellung

All operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls.

Herstellung

All operations of purchase and receipt of materials, production, packaging, labelling, quality control, release, storage and distribution of APIs and the related controls.

Herstellung

includes packaging and labeling operations, testing, and quality control of drug products.

Herstellung

The company which performs the final production steps and release of the product.

Hersteller

All steps neccessary to produce a finished product from raw materials.

Herstellungs-Verfahren

Documentation describing the manufacture of the excipient from raw material to completion of the lot/batch.

A general term used to denote raw materials, starting materials, intermediates, APIs and packaging materials.

Stoff

means any Type B or Type C medicated feed as defined in § 558.3 of this chapter. The feed contains one ore more drugs as defined in section 201(g) of the act. The manufacture of medicated feedis subject to the requirements of part 225 of this chapter.

Fütterungsarzneimittel

means a Type A medicated article as defined in § 558.3 of this chapter. The article contains one ore more drugs as defined in section 201(g) of the act. The manufacture of medicated premixes is subject to the requirements of part 226 of this chapter

Arzneimittelvormischung

The documented successful evaluation of an analytical method that provides a high level of assurance that the method will consistently yield reliable and accurate results, within previously established specifications.

Validierung analytischer Methoden

A product which simulates a group of like products.

Modellprodukt

The residual liquid which remains after the crystallisation or isolation processes. A mother liquor may contain unrecovered products (i.e., unreacted starting materials, intermediates, levels of the API and/or impurities). It may be used for further processing.

Mutterlauge

The residual saturated liquid which remains after the crystallisation of a liquid. A mother liquor may contain unrecovered products (i.e., unreacted starting materials, intermediates, trace levels of the API and/or impurities).

The designated therapeutic moiety which has not been a previously registered in a member state (also referred to as a new molecular entity or new chemical entity). It may be a complex, simple ester, or salt of a previously approved substance.

neuer Wirkstoff

A chemical that has not been adequately characterized in the literature regarding its physical and chemical properties.

neue chemische Wirkstoffe

The designed therapeutic moiety (API) in a dosage form that has not been approved for marketing in the United States (also referred to as a new chemical entity or new drug substance). It may be a complex, simple ester, or salt of a previously approved API.

neue molekulare Wirkstoff (Struktur)

Any material that does not meet manufacturer’s specifications or applicable GMPs.

means any filter, which after any appropriate pretreatment such as washing and flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.

nicht-fasernder Filter

Optional process steps are steps that may be run based on a decision. Such an optional step should be a well defined written process. There should be defined criteria for the decision as to whether or not optional steps will be used.

optionaler Verfahrensschritt

Any Material used to protect an Active Ingredient during storage and transport but excluding labels.

Verpackungsmaterial

Any Material intended to protect an intermediate or API during storage and transport.

Verpackungsmaterial

means the ratio of the actual yield (at any appropriate phase of production of a particular drug substance or intermediate) to the theoretical yield (at the same phase), stated as a percentage.

prozentuale Ausbeute

A process other than chemical reaction that may change the purity or the physical properties of the material, including but not limited to crystallisation, recrystallisation, gel filtration, chromatography, milling, drying or blending.

physikalischer Verfahrensschritt

The manufacture of an API on a reduced scale by processes representative of and simulating those to be applied on a larger commercial manufacturing scale.

Versuchsmaßstab

The occurence of different crystalline forms of the same API.

Polymorphie

An impurity that, from theoretical consider-ations, may arise from or during manufacture. It may or may not actually appear in the API.

mögliche Verunreinigung

A substance that has been shown by an extensive set of analytical tests, to be authentic material of high purity. This standard may be obtained from a recognised source or may be prepared by independent synthesis or by further purification of existing production material.

Primärer Referenz-Standard

A written description of the operations to be carried out, the precautions to be taken and measures to be applied directly or undirectly related to be manufacture of an intermediate or API.

Anweisungen

Description of the operations to be carried out, the precautions to be taken, and measures to be applied directly or undirectly related to the manufacture of an API.

Anweisungen

Materials used as an aid in the manufacture of an API which themselves do not participate in the chemical or biological reaction.

Hilfsstoff

Materials, excludig solvents, used as an aid in the manufacture of an intermediate or API which themselves do not participate in the chemical or biological reaction (e.g. filter aid, activated carbon, etc.).

Hilfsstoff

Also called In-Process Control.

Inprozesskontrolle

Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.

Verfahrensvalidierung

The manufacturing procedures set forth in the Master Formula.

Verfahrensanweisungen

All operation involved in the preparation of an API, from receipt of materials, trough processing and packaging, to its completion as a finished API.

Produktion

Establishing documented evidence that a system does what it purports to do prior to the commercial distribution of a new API or an existing API made by a new or modified process.

prospektive Validierung

The process of removing impurities from a substance.

Reinigung

A process, such as crystallization, distillation, or chromatography, intended to improve the purity of an intermediate, API, or biologic API.

Reinigungsschritt (im Verfahren)

Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.

Qualifizierung

Action of proving that any equipment works correctly and actually leads to the expected results. The word “validation“ is sometimes widened to incorporate to the concept of qualification.

Qualifizierung

The totality of features and characteristics of a product that bear on its ability to satisfy stated or implied needs.

Qualität.

The sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use.

Qualitätssicherung

Any product characteristic which may reflect quality, or may affect safety or efficacy of the product during its expected shelf life.

Qualitätsmerkmal

Checking or testing, that specifications are met and quality systems are maintained.

Qualitätskontrolle

Measurement instruments used to monitor the manufacturing process, in-process controls and the finished excipient products for final quality control approval.

Qualitätskontroll-Instrumente

Any person or organizational element designated by the firm to be responsible for the duties relating to quality control.

Qualitätskontrolleinheit

An organisational unit with defined responsibilities and authority for controlling, through checking or testing, that specifications are met and quality systems are maintained.

Qualitätskontrolleinheit

An organizational unit independent of production which fulfills both Quality Assurance and Quality Control responsibilities. This may be in the form of separate QA and QC units, a single individual (or group), depending upon the size and structure of the organization.

Qualitätskontrolleinheit

The status of materials isolated physically or by other effective means pending a decision on their subsequent use.

Quarantäne

The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.

Quarantäne

The range for each critical process parameter generally developed on research or pilot scale batches that encompasses values that are capable of producing intermediates and APIs with acceptable quality attributes.

Any ingredient intended for use in the production of APIs. These may include starting materials, process aids, solvents and reagents.

Einsatzstoff

Any ingredient intended for use in the production of APIs. These may include starting materials, process aids, and solvents.

Einsatzstoff

A substance, other than a starting material or solvent, that is used in the manufacture of an API or intermediate.

Any treatment of materials by a process intended to make them suitable for further use.

Wiedergewinnung

means the date prior to which the drug substance meets all specifications and beyond which the drug substance shall not be used without prior adequate re-examination. This date shall be based on the stability of the drug substance or experience with the drug substance.

An API of high purity, specifically prepared by independent synthesis or by further purification of existing production material

Referenz - Standard

means any material or item which has been determined to be unacceptable for the specified use.

abgelehnte Ware

Adding fresh reagents or solvents to unreacted or base material and repeating a chemical reaction from its beginning. This excludes those situations where a chemical reaction is continued or extended in the same vessel with the addition of more solvent, to ensure completion of a reaction or increase the yield and/or purity of the API (e.g., continuation of a hydrogenation step).

Wiederholen einer chemischen Reaktion

means a sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled.

repräsentative Probe

means introducing previously processed material, which did not conform to standards or specifications, back into the process and repeating steps which are already part of the normal manufacturing process (e.g. to dry again under the same process/conditions, etc.).

- Wiederholung validierter Verfahrensschritte

- Reprocessing

Repeating a crystallization step or other appropriate chemical or physical manipulation steps such as distillation, filtration, chromatography, milling, etc. according to procedures used to manufacture the original batch. Continuation of a chemical reaction after an inprocess control test shows the reaction to be incomplete is considered to be part of the normal process, and not reprocessing.

- wiederaufarbeiten

Introducing an intermediate or API that does not conform to standards or specifications, back into the process and repeating step(s) that are part of the established manufacturing process, so that its quality may be made acceptable (e.g., recrystallizing using the same solvent).

- wiederaufarbeiten

A representative sample of sufficient quality and quantity needed of the final excipient batch to perform quality control analyses twice.

means that person with the authority to initiate appropriate actions.

- verantwortliche Person

The date when the API should be re-examined to ensure that is still suitable for use.

The date when samples of the API should be re-examined that material is still suitable for use.

- Neuer Prüftermin

The period of time during which the API can be considered to remain within specifications and therefore acceptable for use in the manufacture of a given drug product, provided that it has been stored under defined conditions. After this period, the batch should be retested for compliance with specifications before use.

- Freigabezeitraum

Establishing documented evidences that a sys-tem does what it purports to do based on a re-view and analysis of historic information. It is normally conducted on an API already being commercially distributed and is based on accu-mulated production, testing, and control data.

- retrospektive Validierung

Finished products sent back to the manufacturer.

- zurückgeschichte Produkte

means introducing previously processed material, which did not conform to standards or specifications, to processing steps which are different than the normal process (e.g. to recrystallize with a new solvent, etc.)

- Überarbeitung mit nicht validierten Prozeßschritten

Subjecting an intermediate or API that does not conform to standards or specifications, to one or more processing steps that are different from the established manufacturing process so that its quality may be made acceptable (e.g., recrystallizing with a different solvent).

- Überarbeitung mit nicht validierten Prozeßschritten

A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.

means a facility that provides for a very high degree of containment of materials and prevention of contamination. This may be accomplished by several means such as, separate buildings, a building within a building, or closed systems within a building.

- separate Einrichtung

The record of who performed a particular action or review. This record may be initials, full handwritten signature, or authenticated and secure electronic signature.

- Abzeichnung / Kennzeichnung

Processing steps that are required to produce an excipient that meets the established physical criteria.

- bedeutender Verfahrensschritt

Any liquid used as a vehicle for the preparation of solutions or suspensions in the synthesis of an API or intermediate.

- Lösungsmittel

An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacture of an intermediate or API.

Lösungsmittel

A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which an intermediate or API should conform to be considered acceptable for the intended use. „Conformance to Specifications“ means that the intermediate or API, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.

Spezifikation

The continued conformance of the excipient to its specification.

- Stabilität

A written authorized procedure which gives instructions for performing operations.

- Allgemeine Arbeitsanweisung

A material used in the synthesis of an API, which is incorporated as an element into the structure of an intermediate and/or of the API. Starting materials are normally commercially available and of defined chemical and physical properties and structure.

a) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis) and/or

b) The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).

- Wirkstärke

The quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular API or intermediate, based upon the quantity of components to be used, in the absence of any loss or error in actual production.

theoretische Ausbeute

Impurities having significant undesirable biological activity.

- giftige Verunreinigung

An impurity that is defined solely by qualitative properties (e.g., chromatograpfic retention time).

- nichtidentifizierte Verunreinigung

A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.

Validierung

Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results.

Validierung

A written plan stating how validation will be conducted. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics sampling and test data to be collected, number of validation runs, and acceptable test results.

- Validierungsplan

An organization contracted to supply a material or perform a service.

- Lieferant

An API or biological API of high quality and purity, used as an analytical reference substance for routine laboratory analysis. The analytical testing needed to document the suitability of the working standard should generally be more extensive than that used for the API, and it is compared with a primary reference standard.

- Arbeits-Substanz

[1] 21 CFR 210/211; cGMP for Finished Pharmaceuticals

[2] ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, November 2000

[3] Richtlinien für die Herstellung pharma-zeutischer Wirkstoffe, PIC-Dokument PH 2/87, Juni 1987