Good manufacturing practices for pharmaceuticals : a plan for total quality control (Book, 1997) [WorldCat.org]
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Good manufacturing practices for pharmaceuticals : a plan for total quality control

Author: Sidney H Willig; James R Stoker
Publisher: New York : Dekker, 1997.
Edition/Format:   Print book : English : 4. ed., rev. and expandedView all editions and formats
Summary:

Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP  Read more...

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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Sidney H Willig; James R Stoker
ISBN: 0824797701 9780824797706
OCLC Number: 231692267
Description: x, 496 Seiten : Diagramme.
Contents: Status and applicability of U.S. regulations; finished pharmaceuticals; general provisions; organization and personnel; buildings and facilities; equipment; control of components and drug product containers and closures; production and process controls; packaging and labelling control; holding and distribution; laboratory controls; records and reports; returned and salvaged drug products; repackaging and relabelling; the inspection procedure for compliance in the United States; recalls and CGMPs: enforcement alternatives in the United States; controlled substances safeguards; who is the manufacturer? some additional considerations for the multinational; bulk pharmaceutical chemicals; FDA pre-approved inspections/investigations; other GMPs; other approaches to quality; import and export of pharmaceuticals and other products subject to CGMPs. Appendices: potable water requirements; components/repackagers.
Responsibility: Sidney H. Willig ; James R. Stoker.

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