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Wildy’s Book News

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Vol 23 No 3 March/April 2018

Book of the Month

Cover of Scamell and Gasztowicz on Land Covenants

Scamell and Gasztowicz on Land Covenants

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Good Manufacturing Practices for Pharmaceuticals 4th ed

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ISBN13: 9780824797706
ISBN: 0824797701
Published: August 1996
Publisher: Marcel Dekker Inc
Format: Hardback
Price: £69.00

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 regulations while meeting the goals of a comprehensive controls system to preserve product integrity.

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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.