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Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verifica

Attributes	Values
rdf:type	work
rdfs:label	Prozessvalidierung (de) Process validation (en)
rdfs:comment	Prozessvalidierung ist ein Teilbereich der Validierung in der Pharmazie und bezeichnet die Sammlung und Auswertung von Daten, vom Prozessentwurfsstudium bis zur kommerziellen Produktion.Durch sie wird Sicherheit darüber gewonnen, ob der analysierte Prozess kontinuierlich Qualitätsprodukte herstellen kann. Diese Kontrolle gewährt dem Hersteller einen hohen Grad an Sicherheit und Kontinuität über die Qualität seines Produkts. (de) Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verifica (en)
dcterms:subject	Software testing Business process management Enterprise modelling Formal methods Software quality
Wikipage page ID	44224167 (xsd:integer)
Wikipage revision ID	1035713607 (xsd:integer)
Link from a Wikipage to another Wikipage	Process qualification Software testing Process design Quality by design Continued process verification Critical process parameters Cleaning validation Process analytical technology Critical Process Parameters Critical quality attributes European Medicines Agency FDA Good manufacturing practice Process control Business process management Enterprise modelling Formal methods Software quality Business process validation Verification and validation Product quality
Link from a Wikipage to an external page	https://www.fda.gov/ http://www.atris-systems.com/210.0.html http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/fdas-process-validation-guidance-12-may-2011---presentation-three.pdf%3Fsfvrsn=6 http://www.ema.europa.eu/ema/
sameAs	Process validation Process validation Process validation Process validation Process validation
dbp:wikiPageUsesTemplate	dbt:Commons_category dbt:Reflist
has abstract	Prozessvalidierung ist ein Teilbereich der Validierung in der Pharmazie und bezeichnet die Sammlung und Auswertung von Daten, vom Prozessentwurfsstudium bis zur kommerziellen Produktion.Durch sie wird Sicherheit darüber gewonnen, ob der analysierte Prozess kontinuierlich Qualitätsprodukte herstellen kann. Diese Kontrolle gewährt dem Hersteller einen hohen Grad an Sicherheit und Kontinuität über die Qualität seines Produkts. (de) Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification. (en)
gold:hypernym	Analysis
prov:wasDerivedFrom	wikipedia-en:Process_validation?oldid=1035713607&ns=0
page length (characters) of wiki page	7749 (xsd:nonNegativeInteger)
foaf:isPrimaryTopicOf	wikipedia-en:Process_validation
is Link from a Wikipage to another Wikipage of	Process performance qualification protocol Process qualification Design space verification Critical process parameters Process Validation Cleaning validation Critical Quality Attributes Critical quality attributes Fine chemical Business process validation Verification and validation
is Wikipage redirect of	Process Validation Critical Quality Attributes Critical quality attributes
is foaf:primaryTopic of	wikipedia-en:Process_validation

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