Loại tài liệu: Sách
Establishing a CGMP laboratory audit system: a practical guide / David M. Bliesner. - Hoboken: John Wiley & Sons , 2006. - xv, 277 p. : ill. ; 25 cm. + 1 CD-ROM (4 3/4 in.)- - Preface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- A summary for establishing a CGMP laboratory audit system -- Appendixes -- Example audit checklists: laboratory subelements -- Example template for an audit summary report -- Glossary of CGMP and audit system terms -- FDA compliance program guidance manual 7356.002 "Drug manufacturing inspections" -- 21 Code of U.S Federal Regulations parts 210 and 211 current good manufacturing practice regulations. .
Thông tin tài liệu |
Giá tiền |
1439000 |
Mã ngôn ngữ |
eng |
Chỉ số phân loại DDC |
343.7307/ DAV |
Nhan đề tài liệu |
Establishing a CGMP laboratory audit system: a practical guide / David M. Bliesner |
Xuất bản, phát hành |
Hoboken: John Wiley & Sons , 2006 |
Mô tả vật lý |
xv, 277 p. : ill. ; 25 cm. + 1 CD-ROM (4 3/4 in.) |
Phụ chú chung |
Preface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- A summary for establishing a CGMP laboratory audit system -- Appendixes -- Example audit checklists: laboratory subelements -- Example template for an audit summary report -- Glossary of CGMP and audit system terms -- FDA compliance program guidance manual 7356.002 "Drug manufacturing inspections" -- 21 Code of U.S Federal Regulations parts 210 and 211 current good manufacturing practice regulations. |
Chủ đề |
Drug Industry legislation & jurisprudence |
Chủ đề |
Drug Industry standards |
Chủ đề |
Drugs Law and legislation |
Chủ đề |
Laboratories legislation & jurisprudence |
Chủ đề |
Laboratories standards |
Chủ đề |
Management Audit methods |
Chủ đề |
Pharmaceutical industry |
Từ khóa |
Current Good Manufacturing Practices |
Ký hiệu kho |
CK |
Ký hiệu kho |
Chuyên Khảo. CK.0000016272 |
Kho | Số ĐKCB | Trạng Thái |
Chuyên Khảo | CK.0000016272 |
Trong kho sẵn sàng cho mượn
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Chuyên Khảo | CK.0000019592 |
Trong kho sẵn sàng cho mượn
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