Wildy logo
(020) 7242 5778
enquiries@wildy.com

Wildy’s Book News

Book News cover photo

Vol 21 No 11 Nov/Dec 2016

Book of the Month

Cover of Criminal Injuries Compensation Claims

Criminal Injuries Compensation Claims

Price: £99.95

Pupillage & Student Offers

Special Discounts for Pupils, Newly Called & Students

Read More ...


Secondhand & Out of Print

Browse Secondhand Online

Read More...


Good Manufacturing Practices for Pharmaceuticals 4th ed

Image not available lge

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.

Image not available lge
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.