Good manufacturing practices for pharmaceuticals : a plan for total quality control / Sidney H. Willig, James R. Stoker.
By: Willig, Sidney H.
Contributor(s): Stoker, James R.
Material type: BookSeries: Drugs and the pharmaceutical sciences ; v. 52.Publisher: New York : M. Dekker, 1992Edition: 3rd ed.Description: xvi, 268 p. : ill. ; 24 cm.ISBN: 0824785940.Subject(s): Pharmaceutical industry -- Quality control | Drugs -- Standards -- United States | Pharmaceutical industry -- Standards -- United States | Drugs -- Standards | Quality controlDDC classification: 615.190685Item type | Current library | Call number | Copy number | Status | Date due | Barcode | Item holds |
---|---|---|---|---|---|---|---|
General Lending | MTU Bishopstown Library Lending | 615.190685 (Browse shelf(Opens below)) | 1 | Available | 00024624 |
Enhanced descriptions from Syndetics:
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
Includes bibliographical references and index.
Status and applicability of regulations: current good manufacturing practices in manufacturing, processing, packaging and holding of drugs -- Finished pharmaceuticals: general provisions (Subpart A) -- Organization and personnel: (Subpart B) -- Building and facilities: (Subpart C) -- Equipment: (Subpart D) -- Control of components and drug product containers and closures: (Subpart E) -- Production and process controls: (Subpart F) -- Packaging and labeling control: (Subpart G) -- Holding and distribution: (Subpart H) -- Laboratory controls: (Subpart I) -- Records and reports: (Subpart J) -- Returned and salvaged drug products: (Subpart K) -- Repacking and relabelling -- The inspection for compliance with CGMP: (21 USC 373, 374) -- Recalls and CGMP: The statute and the regulations -- Controlled substances safeguards: (21 CFR 1300, et seq.) -- Who is the manufacturer?