II. What are the different types of audits? • New Supplier Assessment: This audit focuses on getting a general overview of the supplier’s quality systems, as requested by Sourcing Strategy Teams or new Technology exploration • Process/Scheduled Audit: Scheduled audits with key suppliers are identified by SQD Selection Criteria and SST input. These audits use either a GMP or ISO style audit checklist and are designed to review quality processes, procedures, and systems • Developmental Audit: These audits focus on areas for specific improvement and may address a particular corrective action or follow-up. • Verification/Follow-Up Audit: Audit to address implementation of a corrective action to ensure compliance.
{"title":"Supplier Audits","authors":"Leonard Steinborn","doi":"10.1201/9780429135941-4","DOIUrl":"https://doi.org/10.1201/9780429135941-4","url":null,"abstract":"II. What are the different types of audits? • New Supplier Assessment: This audit focuses on getting a general overview of the supplier’s quality systems, as requested by Sourcing Strategy Teams or new Technology exploration • Process/Scheduled Audit: Scheduled audits with key suppliers are identified by SQD Selection Criteria and SST input. These audits use either a GMP or ISO style audit checklist and are designed to review quality processes, procedures, and systems • Developmental Audit: These audits focus on areas for specific improvement and may address a particular corrective action or follow-up. • Verification/Follow-Up Audit: Audit to address implementation of a corrective action to ensure compliance.","PeriodicalId":370822,"journal":{"name":"GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers","volume":"54 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122158653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-04-23DOI: 10.1201/9780429135941-15
Leonard Steinborn
{"title":"Printed Material Supplier Audit Checklist","authors":"Leonard Steinborn","doi":"10.1201/9780429135941-15","DOIUrl":"https://doi.org/10.1201/9780429135941-15","url":null,"abstract":"","PeriodicalId":370822,"journal":{"name":"GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117037934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Quality Audits","authors":"Leonard Steinborn","doi":"10.1201/9780429135941-2","DOIUrl":"https://doi.org/10.1201/9780429135941-2","url":null,"abstract":"","PeriodicalId":370822,"journal":{"name":"GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134232242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regulatory Considerations","authors":"Leonard Steinborn","doi":"10.1201/9780429135941-1","DOIUrl":"https://doi.org/10.1201/9780429135941-1","url":null,"abstract":"","PeriodicalId":370822,"journal":{"name":"GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers","volume":"303 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124282201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Contract Drug Manufacturer/Developer Audit Checklist","authors":"Leonard Steinborn","doi":"10.1201/9780429135941-9","DOIUrl":"https://doi.org/10.1201/9780429135941-9","url":null,"abstract":"","PeriodicalId":370822,"journal":{"name":"GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers","volume":"55 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121557212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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