Validation of pharmaceutical processes. (©2008)
- Record Type:
- Book
- Title:
- Validation of pharmaceutical processes. (©2008)
- Main Title:
- Validation of pharmaceutical processes
- Further Information:
- Note: Edited by James Agalloco, Frederick J. Carleton.
- Other Names:
- Agalloco, James P, 1948-
Carleton, Frederick J, 1925- - Contents:
- Why validation? -- Organizing for validation -- Validation and facility design -- Validation of environmental control systems used in parenteral facilities -- Validation of critical utilities -- The validation of pharmaceutical water systems -- Calibration and metrology -- Temperature measurements -- Qualification and change control -- Microbiology and sterilization processes -- F, D, and z values -- Steam sterilization in autoclaves -- Validation of terminal sterilization -- Steam sterilization-in-place technology and validation -- Dry heat sterilization and depyrogrenation validation and monitoring -- Validation of ethylene oxide sterilization processes -- Validation of chlorine dioxide sterilization -- Validation of the radiation sterilization of pharmaceuticals -- Isolator decontamination -- Validation of sterilizing-grade filters -- Cleaning and disinfction in the control of pharmaceutical cleanrooms -- Aseptic processing for dosage form manufacture : organization and validation -- Validation of aseptic processing for bulk pharmaceutical chemicals -- Validation of manual aseptic processes -- Monitoring of nonviable particles -- Viable environmental microbiological monitoring -- Validation of container preparation processes -- Validation of lyophilization -- Qualification concerns for isolator systems -- Validation of solid dosage finished goods -- Validation of oral/topical liquids and semisolids -- Validation of packaging operations -- Validation of bulk pharmaceuticalWhy validation? -- Organizing for validation -- Validation and facility design -- Validation of environmental control systems used in parenteral facilities -- Validation of critical utilities -- The validation of pharmaceutical water systems -- Calibration and metrology -- Temperature measurements -- Qualification and change control -- Microbiology and sterilization processes -- F, D, and z values -- Steam sterilization in autoclaves -- Validation of terminal sterilization -- Steam sterilization-in-place technology and validation -- Dry heat sterilization and depyrogrenation validation and monitoring -- Validation of ethylene oxide sterilization processes -- Validation of chlorine dioxide sterilization -- Validation of the radiation sterilization of pharmaceuticals -- Isolator decontamination -- Validation of sterilizing-grade filters -- Cleaning and disinfction in the control of pharmaceutical cleanrooms -- Aseptic processing for dosage form manufacture : organization and validation -- Validation of aseptic processing for bulk pharmaceutical chemicals -- Validation of manual aseptic processes -- Monitoring of nonviable particles -- Viable environmental microbiological monitoring -- Validation of container preparation processes -- Validation of lyophilization -- Qualification concerns for isolator systems -- Validation of solid dosage finished goods -- Validation of oral/topical liquids and semisolids -- Validation of packaging operations -- Validation of bulk pharmaceutical chemicals -- Validation of recovery and purification processes -- Validation of process chromatography -- Cell culture process validation -- Cleaning validation for the pharmaceutical, biopharmaceutical, cosmetic, nutraceutical, medical device, and diagnostic industries -- Validation of training -- Vendor qualification and validation -- Validation for clinical manufacturing -- Validation of new products -- Retrospective validation -- Validation and six sigma -- Validation and contract manufacturing -- Process analytical technology and validation -- Computerized systems validation -- Validation of control systems -- Risk-based validation of a laboratory information management system -- Validation of laboratory information systems -- Validation of analytical procedures and physical methods -- Validation of microbiological methods -- Implementation of validation in the United States -- The European approach to validation : a microbiological perspective -- Japanese regulatory requirements -- Managing validation in a multinational company -- Validation in a small pharmaceutical company -- Regulatory aspects of validation -- Validation : what's next? … (more)
- Edition:
- 3rd ed
- Publisher Details:
- New York : Informa Healthcare
- Publication Date:
- 2008
- Copyright Date:
- 2008
- Extent:
- 1 online resource (xvi, 737 pages), illustrations
- Subjects:
- 615/.19
Sterilization
Pharmaceutical technology -- Quality control
Pharmaceutical technology -- Standards
Technology, Pharmaceutical
Quality Control
Sterilization -- methods
MEDICAL -- Drug Guides
MEDICAL -- Nursing -- Pharmacology
MEDICAL -- Pharmacology
MEDICAL -- Pharmacy
Pharmaceutical technology -- Quality control
Pharmaceutical technology -- Standards
Sterilization
Electronic books - Languages:
- English
- ISBNs:
- 1420019791
9781420019797 - Related ISBNs:
- 9780849370557
0849370558 - Notes:
- Note: Includes bibliographical references and index.
Note: Print version record. - Access Rights:
- Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
- Access Usage:
- Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.
- View Content:
- Available online (eLD content is only available in our Reading Rooms) ↗
- Physical Locations:
- British Library HMNTS - ELD.DS.159675
- Ingest File:
- 01_052.xml