Vui lòng dùng định danh này để trích dẫn hoặc liên kết đến tài liệu này:
http://thuvienso.vanlanguni.edu.vn/handle/Vanlang_TV/15118
Toàn bộ biểu ghi siêu dữ liệu
Trường DC | Giá trị | Ngôn ngữ |
---|---|---|
dc.contributor.author | Wechsler, Jill | - |
dc.date.accessioned | 2020-02-11T06:44:50Z | - |
dc.date.available | 2020-02-11T06:44:50Z | - |
dc.date.issued | 2019 | - |
dc.identifier.issn | 1543-2521 | - |
dc.identifier.issn | 2150-7376 (e) | - |
dc.identifier.other | BBKH677 | - |
dc.identifier.uri | http://thuvienso.vanlanguni.edu.vn/handle/Vanlang_TV/15118 | - |
dc.description | Pharmaceutical Technology. Vol 43 (Octorber 2019) | vi |
dc.description.abstract | Falsified documents and manipulated test results prompt warnings and investigations. Because federal investigators cannot inspect every drug test site or production facility, FDA relies on manufacturers to submit complete and accurate information in all submissions and market applications, especially for innovative cell and gene therapies. FDA published final guidance in December 2018 for ensuring data integrity in compliance with current good manufacturing practices (CGMPs) (4), which emphasizes the importance of company top management establishing a "quality culture" that acknowledges the importance and value of data integrity in all aspects of drug development and production. According to press reports, FDA inspectors raised questions about a mouse essay at an inspection of a Novartis manufacturing facility in Illinois earlier this year, but company staff said they had been corrected. | vi |
dc.language.iso | en | vi |
dc.publisher | MultiMedia Healthcare Inc. | vi |
dc.subject | Good Manufacturing Practice | vi |
dc.subject | Evidence | vi |
dc.subject | Data integrity | vi |
dc.subject | Violations | vi |
dc.subject | Manufacturing | vi |
dc.subject | Compliance | vi |
dc.subject | Commodities | vi |
dc.subject | FDA approval | vi |
dc.subject | Enforcement | vi |
dc.subject | Criminal investigations | vi |
dc.title | Data Integrity Violations Draw Strong FDA Rebukes | vi |
dc.type | Working Paper | vi |
Bộ sưu tập: | Bài báo_lưu trữ |
Các tập tin trong tài liệu này:
Tập tin | Mô tả | Kích thước | Định dạng | |
---|---|---|---|---|
BBKH677_TCCN_Data Integrity Violations Draw Strong.pdf Giới hạn truy cập | Data Integrity Violations Draw Strong FDA Rebukes | 270.76 kB | Adobe PDF | Xem/Tải về Yêu cầu tài liệu |
Khi sử dụng các tài liệu trong Thư viện số phải tuân thủ Luật bản quyền.