TY - BOOK AU - Sharp,John TI - Good pharmaceutical manufacturing practice: rationale and compliance SN - 0849319943 (alk. paper) AV - RS189 .S524 2005 U1 - 615.362178273 22 PY - 2005/// CY - New York PB - CRC Press KW - Drugs KW - Standards KW - United States KW - European Union Countries KW - Pharmaceutical industry KW - Quality control KW - Law and legislation N1 - Includes bibliographical references and index; Introduction: status and applicability of US regulations/EU guidelines - general quality issues -- Personnel, organization, and training -- Premises/buildings and facilities -- Contamination and contamination control -- Equipment -- Materials control -- Production and process controls -- Packaging and labeling control -- Holding and distribution -- Laboratory controls -- Records and reports -- Returned and salvaged drug products -- Sterile products manufacture - basic principles -- GMP and quality assurance in sterile products manufacture -- Validation - general principles -- Validation - applications -- Self-inspection and quality audit -- US cGMPs and EC GMP guide - concluding comparison; TOC; Pharmacy N2 - Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP Guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices."--BOOK JACKET UR - http://www.loc.gov/catdir/enhancements/fy0646/2004050322-d.html UR - http://www.worldcat.org/title/good-pharmaceutical-manufacturing-practice-rationale-and-compliance/oclc/55149519&referer=brief_results UR - http://lib.ewubd.edu/ebook/5754 ER -