Good Manufacturing Practices for Pharmaceuticals A Plan for Total Quality Control

Name: Good Manufacturing Practices for Pharmaceuticals A Plan for Total Quality Control
Availability: OutOfStock
ISBN: 9780824785949

ISBN-10: 0824785940

ISBN-13: 9780824785949

Edition: 3rd

Authors: Sidney H. Willig, James R. Stoker

List price: $99.75

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Description:

A volume geared toward use as a resource for private and independent inspection companies, local and state inspection agencies, quality assurance organizations, and pharmaceutical manufacturers. Provides an examination of US laws affecting domestic and multinational production, and recommends practical ways to interpret and comply with regulations while meeting the goals of a comprehensive control system for product integrity. Annotation copyrighted by Book News, Inc., Portland, OR

Book details

List price: $99.75
Edition: 3rd
Publisher: Marcel Dekker Incorporated
Binding: Hardcover
Pages: 256
Weight: 1.408
Language: English



Preface to the Fourth Edition


Introduction to the Fourth Edition


Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holding of Drugs


Finished Pharmaceuticals


Organization and Personnel


Buildings and Facilities


Equipment


Control of Components and Drug Product Containers and Closures


Production and Process Controls


Packaging and Labeling Control


Holding and Distribution


Laboratory Controls


Records and Reports


Returned and Salvaged Drug Products


Repackaging and Relabeling


The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected; The Rationale for Inspection


Recalls ad 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-Approval Inspections/Investigations


Other GMPs


Other Approaches to Quality


Import and Export of Pharmaceuticals and Other Products Subject to CGMPs


Potable Water Requirements


Components/Repackagers


Hearing Procedures When FDA Proposes the Imposition of Civil Money Penalties


Section 601.12 Changes Currently Considered "Important" by CBER


Index