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- Validation_(drug_manufacture) abstract "In the pharmaceutical, for medical device, food, blood products, biological products, tissue, establishments, clinical trials conducting institutions, validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages. In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results. Here the desired results are established in terms of specifications for out come of the process. Qualification of systems and equipment is therefore a part of process of validation. It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:Equipment validationFacilities validationHVAC system validationCleaning validationProcess validationAnalytical method validationComputer system validationPackaging validationCold chain validationSimilarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:Design qualification (DQ)Component qualification (CQ)Installation qualification (IQ)Operational qualification (OQ)Performance qualification (PQ)↑".
- Validation_(drug_manufacture) wikiPageExternalLink Instrumentation1_Swartz_rv.pdf.
- Validation_(drug_manufacture) wikiPageExternalLink about-21-cfr-part-11-electronic-records-electronic-signatures.
- Validation_(drug_manufacture) wikiPageExternalLink www.ccs-inspired.com:.
- Validation_(drug_manufacture) wikiPageExternalLink ucm124720.html.
- Validation_(drug_manufacture) wikiPageExternalLink index-eng.php.
- Validation_(drug_manufacture) wikiPageExternalLink www.pharmacistspharmajournal.org.
- Validation_(drug_manufacture) wikiPageExternalLink validation.htm.
- Validation_(drug_manufacture) wikiPageID "4639454".
- Validation_(drug_manufacture) wikiPageRevisionID "606657913".
- Validation_(drug_manufacture) hasPhotoCollection Validation_(drug_manufacture).
- Validation_(drug_manufacture) subject Category:Clinical_data_management.
- Validation_(drug_manufacture) subject Category:Clinical_research.
- Validation_(drug_manufacture) subject Category:Pharmaceutical_industry.
- Validation_(drug_manufacture) subject Category:Quality.
- Validation_(drug_manufacture) subject Category:Validity_(statistics).
- Validation_(drug_manufacture) comment "In the pharmaceutical, for medical device, food, blood products, biological products, tissue, establishments, clinical trials conducting institutions, validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.".
- Validation_(drug_manufacture) label "Validatie (farmaceutisch)".
- Validation_(drug_manufacture) label "Validation (drug manufacture)".
- Validation_(drug_manufacture) label "Validazione (industria farmaceutica)".
- Validation_(drug_manufacture) label "Validierung (Pharmatechnik)".
- Validation_(drug_manufacture) label "تثبت (صناعة الدواء)".
- Validation_(drug_manufacture) sameAs Validierung_(Pharmatechnik).
- Validation_(drug_manufacture) sameAs Validazione_(industria_farmaceutica).
- Validation_(drug_manufacture) sameAs Validatie_(farmaceutisch).
- Validation_(drug_manufacture) sameAs m.0cdzqv.
- Validation_(drug_manufacture) sameAs Q359176.
- Validation_(drug_manufacture) sameAs Q359176.
- Validation_(drug_manufacture) wasDerivedFrom Validation_(drug_manufacture)?oldid=606657913.
- Validation_(drug_manufacture) isPrimaryTopicOf Validation_(drug_manufacture).