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- Process_performance_qualification_protocol abstract "Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process. The Food and Drug Administration recommends the following criteria be included in a PPQ protocol:Manufacturing conditions: Operating parameters, equipment limits, and component inputsWhat data should be recorded and analyzedWhat tests should be performed to ensure quality at each production stepA sampling plan to outline sampling methods both during and between production batchesAnalysis methodology that allows for data scientific and risk oriented decision making based on statistical data. Variability limits should be defined and contingencies in the event of non-conforming data establishedApproval of PPQ protocol from relevant departmentsDeviations from the standard operation procedures should be made within the framework of the protocol and at the approval of relevant quality control departments. The protocol should cover all aspects of production including: equipment, personnel, raw materials, and operating environment. The FDA further recommends a documentation of the protocol be published internally. The report should include:A summation of relevant data and analysis from the protocolAn explanation of unexpected data and any other results not mandated by the protocol and its effects on production qualityIdentify correlating effects and suggest changes to existing processesConclude if the process performance is adequately qualified to meet performance standards. Should production standards not be met appropriate changes should be outlined↑ ↑".
- Process_performance_qualification_protocol wikiPageExternalLink 2013_CMCJ_LambertWendy.pdf.
- Process_performance_qualification_protocol wikiPageExternalLink 04d-0001-bkg0001-10-sg3_n99-10_edition2.pdf.
- Process_performance_qualification_protocol wikiPageID "44740826".
- Process_performance_qualification_protocol wikiPageLength "2731".
- Process_performance_qualification_protocol wikiPageOutDegree "10".
- Process_performance_qualification_protocol wikiPageRevisionID "684615931".
- Process_performance_qualification_protocol wikiPageWikiLink Category:Business_process.
- Process_performance_qualification_protocol wikiPageWikiLink Category:Enterprise_modelling.
- Process_performance_qualification_protocol wikiPageWikiLink Category:Formal_methods.
- Process_performance_qualification_protocol wikiPageWikiLink Category:Pharmaceutical_industry.
- Process_performance_qualification_protocol wikiPageWikiLink Category:Process_management.
- Process_performance_qualification_protocol wikiPageWikiLink Category:Validity_(statistics).
- Process_performance_qualification_protocol wikiPageWikiLink Food_and_Drug_Administration.
- Process_performance_qualification_protocol wikiPageWikiLink Process_qualification.
- Process_performance_qualification_protocol wikiPageWikiLink Process_validation.
- Process_performance_qualification_protocol wikiPageWikiLink Quality_control.
- Process_performance_qualification_protocol wikiPageWikiLinkText "Process performance qualification protocol".
- Process_performance_qualification_protocol wikiPageUsesTemplate Template:Commons_category.
- Process_performance_qualification_protocol wikiPageUsesTemplate Template:Reflist.
- Process_performance_qualification_protocol subject Category:Business_process.
- Process_performance_qualification_protocol subject Category:Enterprise_modelling.
- Process_performance_qualification_protocol subject Category:Formal_methods.
- Process_performance_qualification_protocol subject Category:Pharmaceutical_industry.
- Process_performance_qualification_protocol subject Category:Process_management.
- Process_performance_qualification_protocol subject Category:Validity_(statistics).
- Process_performance_qualification_protocol hypernym Component.
- Process_performance_qualification_protocol type MilitaryUnit.
- Process_performance_qualification_protocol comment "Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.".
- Process_performance_qualification_protocol label "Process performance qualification protocol".
- Process_performance_qualification_protocol sameAs Q22907934.
- Process_performance_qualification_protocol sameAs m.012hdbd1.
- Process_performance_qualification_protocol sameAs Q22907934.
- Process_performance_qualification_protocol wasDerivedFrom Process_performance_qualification_protocol?oldid=684615931.
- Process_performance_qualification_protocol isPrimaryTopicOf Process_performance_qualification_protocol.