Abkürzungen, Übersetzungen und Definitionen aus dem Bereich QM, GMP und ATMP sowie Zellkultur

5W: 5 Ws: Wer hat Was Wann Wie gemacht und Warum ?

6M: Mensch, Maschine, Methode, Material, Milieu, Management (Protokollierung)

AA: Arbeitsanweisung

ADI: acceptable daily intake von Rückständen, 1/ooo x NOEL vgl. Reinigungsvalidierung

AM: Arzneimittel

AMG: Arzneimittelgesetz

AMWHV: Arzneimittel und Wirkstoff-Herstellungsverordnung

APS: aseptische Prozesssimulation, aseptic process simulation = media fill (GMP LF Annex 1, 2022)

AQS: (LAWA)

BAM: Bundesamt f. Materialprüfung

BLAC: Bund/Länder Arbeitsgemeinschaft Chemikaliensicherheit (www.blac.de)

BfArM: Bundesamt für Arzneimittel und Medizinprodukte

BfR: Bundesamt für Risikobewertung

BFS: Blow-Fill-Seal (GMP LF Annex 1, 2022)

BVL: Bundesministerium für Verbraucherschutz und Landwirtschaft

BzgA: Bundeszentrale für gesundheitliche Aufklärung (www.bzga.de)

CAPA: Corrective And Preventive Actions

CCS: Contamination Control Strategy (GMP LF Annex 1, 2022)

CE: Conformite europeenne, Eigenangabe, nicht immer unabhängig kontrolliert

CFU: Colony Forming Unit  (GMP LF Annex 1, 2022)

CIP: Clean-In-Place

CMC: Critical Micelle Concentration, vgl. Reinigungsvalidierung, Oberflächensp.

COTS: Commercial Of The Shelf

CPGM: Compliance Program Guide Manual (Inspektoren Guide www.fda.gov)

CPMP: Comitee for Proprietary Medicinal Products (EMA)

CPP: Critical Process Parameters

CSV: Computer System Validation

DAR: Dt.AkkreditierungsRat, www.dar.bam.de

DKD: Deutscher KalibrierDienst

DAKKS: Deutsche AKKreditierungsStelle (seit 1.1.210 eine Organisation)

DIMDI: Deutsches Institut für Medizinische Dokumentation und Information (www.dimdi.de)

DoE: Design of Experiments

DQ: Design Qualification (URS, FS)

EC: European Commision

EMA: European Medicines Agency vor 2011 EMEA

EMEA: European Medicines Agency seit 2011 EMA

EDM: Electronic Document Management

EDMI: Entscheiden, Durchführen, Mitwirken, Informieren

EDQM: European Directorate for the Quality of Medicines
(gibt Eur. Pharm. heraus)

EPA: Environmental Protection Agency

FDA: Food and Drug Administration, US AM Zulassungsbehörde

FFS: Form-Fill-Seal (GMP LF Annex 1, 2022)

FLI: Friedrich Löffler Institut

FMEA: Failure mode and Effects Analysis
(FehlerMöglichkeiten und EinflußAnalyse, vgl. DIN EN / IEC60812)

FS: Functional Specification = Pflichtenheft

G-BA: Gemeinsamer Bundesausschuss (G-BA), das oberste Beschlussgremium der gemeinsamen Selbstverwaltung der Ärzte, Zahnärzte, Psychotherapeuten, Krankenhäuser und Krankenkassen in Deutschland

GACP: Good Agricultural and Colletion Practise

GAMP: Good Automated Manufacturing Practise

GCP: Good Clinical Practise

GDP: Good Documentation Practise

GDP: Good Distribution Practise

GLP: Good Laboratory Practise, Zulassung über Bundesstelle, Dt. Gesellschaft f. gute Forschungspraxis www.dggf.de, Gegenseitige Anerkennung FDA und Europa

GMP: Good Manufacturing Practise

GxP: Zusammenfassung von GMP; GLP, GCP ect.tc, aller gesetzlich geregelten

HMA: Heads of Medicines Agencies

HCT/Ps: Human Cell and Tissue-based Products (vgl. ATMP, TEMP)

IC: In Compliance

ICH: International Conference on Harmonisation (www.ich.org)

IEC: Internation Electrotechnical Commision (www.iec.ch, z.B. FMEA)

ILAC: Int. lab accreditation council www.ilac.de

IQ: Istallation Qualification

IQWiG: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen

ISO: International Standardisation Organisation, Sitz in der Schweiz, globale Normierung, DIN und DIN EN, dreisprachig, Normen Bezug über www.Beuth.de

ISO15189: Medizinische Laboratorien (human)

KBV: Kassenärztliche Bundesvereinigung (www.kbv.de)

LP(E): Leiter der Prüfeinrichtung (GLP)

MACO: maximal acceptable carry over, ADI * Chargengröße Folgeprodukt/max. Tagesdosis Folgeprodukt [mg]; vgl. Reinigung

MD: Medical Device (Medizinprodukt)

MP: dt. Medizinprodukt = Medicinal Device

MP: engl. Medicinal product = Arzneimittel

NOEL: no observed effect level (5/10.000 d. LD50 =mg/kg/d)

OECD: Organisation for Economic Co-operation and Development (REACH)

OIE: Office International des Epizooties à BSE risk categories

OOS: Out Of Spec (measurements)

OQ: Operational Qualification

PDA: Parenteral Drug Association (www.pda.org), non-profit organization

PDCA: Plan Do Check Act, Lernperspektive im QMS

PE: Prüf-Einrichtung (GLP)

PEI: Paul-Ehrlich Institut
(Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel)

PIC/S: Pharmaceutical Inspection Co-operation Scheme
(PICS seit 1992 wortgleich mit EU-GMP Leitfaden,
skandinavische und canadische Behörden, www.picscheme.org)

PL: Prüf-Leiter (GLP)

PS: Prüf-Standort (GLP)

PSUR: Periodic safety up-date report (Pharmacovigilanz)

PQ: Performance Qualification

QAU: Quality Assurance Unit

QbD: Quality by Design

QSE: QualitätsSicherheitsEinrichtung

QMB: QualitätsManagement Beauftragter

QMH: QualitätsManagement Handbuch

QSIT: Quality Systems Inspection Techniques vgl. CPGM der FDA

QMS: QualitätsManagementSystem

RABS: Restricted Access Barriers Systems (GMP LF Annex 1, 2022)

RTP: Rapid Transfer System/Port (GMP LF Annex 1, 2022)

RiLiBÄK: RichtLinie der BundesÄrzteKammer

RPS: Risikoprioritätszahl (FMEA)

SAL: sterility assurance level (GMP LF Annex 1, 2022)

SIP: Sterile-In-Place

SOP: Standard Operating Procedure

SQA: Society for Quality Assurance (www.sqa.org)

SUS: single use system - Einmalartikel (GMP LF Annex 1, 2022)

TEP: Tissue Engineering Product

TEMP: Normative Abk. Tissue Engineering Medicinal Product
(AM oder MP)

TOC: Total Oxidizable Carbon, vgl. Reinigungsvalidierung, Ph. Eur. 2.2.44

TQM: Total Quality Management, QMS z.B. bei Toyota

URS: User Requirements Specification = Lastenheft

VA: Verfahrensanweisung

VMI: Verantwortung, Mitwirkung, Information

VMP: Validation Master Plan

VP: Validation Plan

VR: Validation Report

WHO: World Health Organisation

Zertifizierung: nach z.B. ISO9001, durch z.B. TÜV, DEKRA etc, zertifiziert Unternehmen, nicht das Produkt

ZLG: Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (www.zlg.de)

 

Übersetzungen QM, GMP und ATMP Terminologie

Englisch	Deutsch
Deviation	Abweichung
Change	Änderung
CAPA	CAPA
Directive	Direktive, Richtlinie, muss national gesetzlich implementiert und umgesetzt werden
Functional specification	Lastenheft
OOS	OOS, Prüfergebnis außerhalb der Spezifikation
Potency	Wirksamkeit
Qualification protocol	Qualifizierungsplan besser Qualifizierungsprotokoll
Qualification report	Qualifizierungsbericht besser Qualifizierungsreport
Regulation	Verordnung, direkt in Mitgliedstaaten gültig, keine nationale Implementierung nötig
Specification	Spezifikation, Festlegungen und Anforderungen (AMWHV)
URS (user requirement specification)	Lastenheft

 

Definitionen QM, GMP und ATMP

Im Folgenden sind einige wichtige Definitionen aus QM und GMP Richtlinien und Leitfäden aufgeführt.

Grade A air supply –
Air which is passed through a filter qualified as capable of producing grade A total particle quality air, but where there is no requirement to perform continuous total particle monitoring or meet grade A viable monitoring limits. Specifically used for the protection of fully stoppered vials where the cap has not yet been crimped.EU GMP
Leidfaden
Annex 1 v2022

Begriff und Definition	Quelle
Autologous use - means cells or tissues removed from and applied in the same person.	DIR 2004 / 23
Bioburden - The level and type (i.e. objectionable or not) of micro-organism present in raw materials, media, biological substances, intermediates or products. Regarded as contamination when the level and/ or type exceed specifications.	EU GMP Leidfaden Annex 2
Campaign manufacture – A manufacture of a series of batches of the same product in sequence in a given period of time with strict adherence to established and validated control measures.	EU GMP Leidfaden Annex 1 v2022
Colony Forming Unit (CFU) – A microbiological term that describes a single detectable colony that originates from one or more microorganisms. Colony forming units are typically expressed as CFU per ml for liquid samples, CFU per m3 for air sample and CFU per sample for samples captured on solid medium such as settle or contact plates.	EU GMP Leidfaden Annex 1 v2022
Contamination – The undesired introduction of impurities of a microbiological nature (quantity and type of microorganisms, pyrogen), or of foreign particle matter, into or onto a raw material, intermediate, active substance or drug product during production, sampling, packaging or repackaging, storage or transport with the potential to adversely impact product quality.	EU GMP Leidfaden Annex 1 v2022
Decontamination – The overall process of removal or reduction of any contaminants (chemical, waste, residue or microorganisms) from an area, object, or person. The method of decontamination used (e.g. cleaning, disinfection, sterilisation) should be chosen and validated to achieve a level of cleanliness appropriate to the intended use of the item decontaminated. See also Bio-decontamination.	EU GMP Leidfaden Annex 1 v2022
Disinfection – The process by which the reduction of the number of microorganisms is achieved by the irreversible action of a product on their structure or metabolism, to a level deemed to be appropriate for a defined purpose.	EU GMP Leidfaden Annex 1 v2022
Endotoxin – A pyrogenic product (i.e. lipopolysaccharide) present in the Gram negative bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death.	EU GMP Leidfaden Annex 1 v2022
Ex-vivo - Where procedures are conducted on tissues or cells outside the living body and returned to the living body.	EU GMP Leidfaden Annex 2
Extractables - Chemical entities that migrate from the surface of the process equipment, exposed to an appropriate solvent at extreme conditions, into the product or material being processed.	EU GMP Leidfaden Annex 1 v2022
Feeder cells - Cells used in co-culture to maintain pluripotent stem cells. For human embryonic stem cell culture, typical feeder layers include mouse embryonic fibroblasts (MEFs) or human embryonic fibroblasts that have been treated to prevent them from dividing.	EU GMP Leifaden Annex 2
Intrinsic sterile connection device – A device that reduces the risk of contamination during the connection process; these can be mechanical or fusion sealing.	EU GMP Leidfaden Annex 1 v2022
Isolator – An enclosure capable of being subject to reproducible interior bio-decontamination, with an internal work zone meeting grade A conditions that provides uncompromised, continuous isolation of its interior from the external environment (e.g. surrounding cleanroom air and personnel). There are two major types of isolators: i. Closed isolator systems exclude external contamination of the isolator’s interior by accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of openings to the surrounding environment. Closed systems remain sealed throughout operations. ii. Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g. using continuous overpressure) to exclude the entry of external contaminant into the isolator.	EU GMP Leidfaden Annex 1 v2022
Leachables – Chemical entities that migrate into products from the product contact surface of the process equipment or containers under normal condition of use and/or storage.	EU GMP Leidfaden Annex 1 v2022
Master cell bank (MCB) - An aliquot of a single pool of cells which generally has been prepared from the selected cell clone under defined conditions, dispensed into multiple containers and stored under defined conditions. The MCB is used to derive all working cell banks. Master virus seed (MVS) – as above, but in relation to viruses; master transgenic bank – as above but for transgenic plants or animals.	EU GMP Leidfaden Annex 2
Overkill sterilisation – A process that is sufficient to provide at least a 12 log10 reduction of microorganisms having a minimum D-value of 1 minute.	EU GMP Leidfaden Annex 1 v2022
Pyrogen – A substance that induces a febrile reaction in patients receiving injections.	EU GMP Leidfaden Annex 1 v2022
Raw material – Any ingredient intended for use in the manufacture of a sterile product, including those that may not appear in the final drug product.	EU GMP Leidfaden Annex 1 v2022
Scaffold - a support, delivery vehicle or matrix that may provided structure for or facilitate the migration, binding or transport of cells and/or bioactive molecules.	EU GMP Leifaden Annex 2
Somatic cells - Cells, other than reproductive (germ line) cells, which make up the body of a human or animal. These cells may be autologous (from the patient), allogeneic (from another human being) or xenogeneic (from animals) somatic living cells, that have been manipulated or altered ex vivo, to be administered in humans to obtain a therapeutic, diagnostic or preventive effects.	EU GMP Leidfaden Annex 2
Specified pathogen free (SPF) - Animal materials (e.g. chickens, embryos or cell cultures) used for the production or quality control of biological medicinal products derived from groups (e.g. flocks or herds) of animals free from specified pathogens. Such flocks or herds are defined as animals sharing a common environment and having their own caretakers who have no contact with non-SPF groups.	EU GMP Leidfaden Annex 2
Sterile Product – For purpose of this guidance, sterile product refers to one or more of the sterilised elements exposed to aseptic conditions and ultimately making up the sterile active substance or finished sterile product. These elements include the containers, closures, and components of the finished drug product. Or, a product that is rendered sterile by a terminal sterilisation process.	EU GMP Leidfaden Annex 1 v2022
Tissue engineered product - means a product that contains or consists of engineered cells or tissues, and is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue.	REG 2007 1394
Working cell bank (WCB) - a homogeneous pool of micro-organisms or cells, that are distributed uniformly into a number of containers derived from a MCB that are stored in such a way to ensure stability and for use in production. Working virus seed (WVS) – as above but in relation to viruses, working transgenic bank – as above but for transgenic plants or animals.	EU GMP Leidfaden Annex 2