Good manufacturing practices for pharmaceuticals : a plan for total quality control /
Willig, Sidney H., 1919-
Good manufacturing practices for pharmaceuticals : a plan for total quality control / Sidney H. Willig, James R. Stoker. - Fourth edition, revised and expanded. - x, 496 pages : illustrations ; 24 cm. - Drugs and the pharmaceutical sciences ; v. 78 .
Includes bibliographical references and index.
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.
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.
0824797701 (acidfree paper)
96031653
Pharmaceutical industry--Quality control.
Drugs--Standards--United States.
Drugs--standards--United States.
Drug Industry--standards--United States.
Technology, Pharmaceutical--standards--United States.
Quality Control.
Legislation, Drug--United States.
RS189 / .W57 1997
615.190685 / W.S.G
W1 DR893B v.78 1997 QV 771 W732g 1997
Good manufacturing practices for pharmaceuticals : a plan for total quality control / Sidney H. Willig, James R. Stoker. - Fourth edition, revised and expanded. - x, 496 pages : illustrations ; 24 cm. - Drugs and the pharmaceutical sciences ; v. 78 .
Includes bibliographical references and index.
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.
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.
0824797701 (acidfree paper)
96031653
Pharmaceutical industry--Quality control.
Drugs--Standards--United States.
Drugs--standards--United States.
Drug Industry--standards--United States.
Technology, Pharmaceutical--standards--United States.
Quality Control.
Legislation, Drug--United States.
RS189 / .W57 1997
615.190685 / W.S.G
W1 DR893B v.78 1997 QV 771 W732g 1997