| Edition |
International third edition, revised and expanded. |
| Description |
xxxvi, 860 pages : illustrations ; 24 cm. |
| Series |
Drugs and the pharmaceutical sciences ; 129 |
|
Drugs and the pharmaceutical sciences ; v. 129.
|
| Bibliography |
Includes bibliographical references and index. |
| Contents |
Regulatory basis for process validation -- Prospective process validation -- Retrospective validation -- Sterilization validation -- Validation of solid dosage forms -- Validation for medical devices -- Validation of biotechnology processes -- Transdermal process validation -- Validation of lyophilization -- Validation of inhalation aerosols -- Process validation of phamaceutical ingredients -- Qualification of water and air handling systems -- Equipment and facility qualification -- Validation and verification of cleaning processes -- Validation of analytical methods and processes -- Computer system validation: controlling the manufacturing process -- Integrated packaging validation -- Analysis of retrospective production data using quality control charts -- Statistical methods for uniformity and dissolution testing -- Change control and SUPAC -- Process validation and quality assurance -- Validation in contract manufacturing -- Terminology of nonaseptic proess validation -- Harmonization GMPs, and validation. |
| Subject |
Pharmaceutical industry -- Quality control.
|
|
Drugs -- Standards -- United States.
|
|
Drug Evaluation -- standards -- United States.
|
|
Drug Industry -- standards -- United States.
|
|
Quality Control -- United States.
|
| Added Author |
Berry, Ira R., 1942-
|
|
Nash, Robert A., 1930-
|
| ISBN |
0824708385 alkaline paper |
|
9780824708382 alkaline paper |
|
