책 이미지
eBook 미리보기
책 정보
· 제목 : Solid Oral Dose Process Validation, Volume Two: Lifecycle Approach Application (Hardcover, 2019)
· 분류 : 외국도서 > 의학 > 약리학
· ISBN : 9783030274832
· 쪽수 : 108쪽
· 출판일 : 2019-09-20
· 분류 : 외국도서 > 의학 > 약리학
· ISBN : 9783030274832
· 쪽수 : 108쪽
· 출판일 : 2019-09-20
목차
Preface, Introduction, Chapter 1: Stage 1 Quality by Design Product Development QbD product development methodologies.- Chapter 2: Stage 1 Scale Up, Tech Transfer Process.- Considerations for process scale up and transfer.- Chapter 3: Stage 2 Batch determination, Sampling & Testing Plan.- PPQ batch determination method, scientifically supported sampling and testing plans.- Chapter 4: Stage 3A Continued Process Verification.- Stage 3A assessment methodology for newly launched products.- Chapter 5: Stage 3B Continued Process Verification.- Routine CPV monitoring plan for commercial products.
