{"title":"实施上市后合规和产品成功的持续工艺验证计划:在2025年PDA周上展示的海报。","authors":"Anthony Stewart","doi":"10.5731/pdajpst.2025.25424","DOIUrl":null,"url":null,"abstract":"<p><p>Continued Process Verification (CPV) is the third stage of the FDA Process Validation guideline and is a critical component of modern pharmaceutical manufacturing, ensuring that processes remain in a state of control throughout the product lifecycle. However, CPV has historically been overlooked, with many companies unaware of the need for CPV program implementation as a regulatory requirement. This poster uses a case study to describe the key steps for successful CPV program implementation using a phased-approach for both legacy, approved products, as well as products entering process validation.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"470-471"},"PeriodicalIF":0.0000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Implementation of Continued Process Verification Program for Post-Market Compliance and Product Success: Poster Presented at PDA Week 2025.\",\"authors\":\"Anthony Stewart\",\"doi\":\"10.5731/pdajpst.2025.25424\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Continued Process Verification (CPV) is the third stage of the FDA Process Validation guideline and is a critical component of modern pharmaceutical manufacturing, ensuring that processes remain in a state of control throughout the product lifecycle. However, CPV has historically been overlooked, with many companies unaware of the need for CPV program implementation as a regulatory requirement. This poster uses a case study to describe the key steps for successful CPV program implementation using a phased-approach for both legacy, approved products, as well as products entering process validation.</p>\",\"PeriodicalId\":19986,\"journal\":{\"name\":\"PDA Journal of Pharmaceutical Science and Technology\",\"volume\":\"79 4\",\"pages\":\"470-471\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"PDA Journal of Pharmaceutical Science and Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5731/pdajpst.2025.25424\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"PDA Journal of Pharmaceutical Science and Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5731/pdajpst.2025.25424","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
Implementation of Continued Process Verification Program for Post-Market Compliance and Product Success: Poster Presented at PDA Week 2025.
Continued Process Verification (CPV) is the third stage of the FDA Process Validation guideline and is a critical component of modern pharmaceutical manufacturing, ensuring that processes remain in a state of control throughout the product lifecycle. However, CPV has historically been overlooked, with many companies unaware of the need for CPV program implementation as a regulatory requirement. This poster uses a case study to describe the key steps for successful CPV program implementation using a phased-approach for both legacy, approved products, as well as products entering process validation.