LEADER 03573nam 22005775 450 001 9910988285203321 005 20250320115241.0 010 $a3-031-86504-9 024 7 $a10.1007/978-3-031-86504-6 035 $a(CKB)38012104400041 035 $a(DE-He213)978-3-031-86504-6 035 $a(MiAaPQ)EBC31973333 035 $a(Au-PeEL)EBL31973333 035 $a(EXLCZ)9938012104400041 100 $a20250320d2025 u| 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aPharmaceutical Manufacturing Deviation and Failure Investigations $ePrinciples, Practices, and Case Studies /$fby Ajay Babu Pazhayattil, Sanjay Sharma 205 $a1st ed. 2025. 210 1$aCham :$cSpringer Nature Switzerland :$cImprint: Springer,$d2025. 215 $a1 online resource (XIII, 152 p. 49 illus., 38 illus. in color.) 225 1 $aAAPS Introductions in the Pharmaceutical Sciences,$x2522-8358 ;$v3 311 08$a3-031-86503-0 327 $aChapter 1: Initial Actions and Information Gathering -- Chapter 2: Root Cause Analysis (RCA) Methods -- Chapter 3: Analytical Tools for Investigation and Generation of Supporting Evidence -- Chapter 4: Management of Deviation and Failure Investigation -- Chapter 5: Post-RCA Impact Assessment, CAPA, and Effectiveness Checks -- Chapter 6: Case Study: Dissolution OOT Observed for an Extended-Release Tablet Formulation -- Chapter 7: Case Study: OOS Uniformity of Dosage Units (Stratified Samples) for a Capsule Formulation -- Appendix I: Non-Conformance/Deviation Investigation -- Appendix II: OOS Failure Investigation -- Appendix III: Review of CDMO Investigation Report. 330 $aThis book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the indispensable necessity of a robust investigation. The textbook thoroughly explores the standard tools and techniques for conducting scientifically grounded and data-driven investigations. Its overarching objective is to elucidate systematic investigation methodologies that yield effective corrective and preventive actions, ultimately reducing regulatory risks. This book offers a comprehensive overview of standard tools and techniques, focusing on science-based and data-driven approaches. Tailored for professionals in pharmaceutical manufacturing, this book is your go-to resource for mastering investigations in the manufacturing of patient-critical pharmaceutical products. 410 0$aAAPS Introductions in the Pharmaceutical Sciences,$x2522-8358 ;$v3 606 $aPharmacology 606 $aPharmacy 606 $aPharmacovigilance 606 $aPharmacology 606 $aPharmacy 606 $aDrug Safety and Pharmacovigilance 615 0$aPharmacology. 615 0$aPharmacy. 615 0$aPharmacovigilance. 615 14$aPharmacology. 615 24$aPharmacy. 615 24$aDrug Safety and Pharmacovigilance. 676 $a615 700 $aPazhayattil$b Ajay Babu$4aut$4http://id.loc.gov/vocabulary/relators/aut$01057742 702 $aSharma$b Sanjay$4aut$4http://id.loc.gov/vocabulary/relators/aut 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910988285203321 996 $aPharmaceutical Manufacturing Deviation and Failure Investigations$94348930 997 $aUNINA