| Titre : |
Handbook of validation in pharmaceutical processes |
| Type de document : |
texte imprimé |
| Auteurs : |
James Agalloco, Auteur ; Phil Desantis, Auteur |
| Editeur : |
CRC Presse |
| Année de publication : |
2022 |
| Importance : |
1043p. |
| Présentation : |
ill. |
| Format : |
28cm x 22m |
| ISBN/ISSN/EAN : |
978-0-367-75606-2 |
| Langues : |
Anglais (eng) Langues originales : Anglais (eng) |
| Index. décimale : |
615 Pharlacikigue et thérapeutique |
| Résumé : |
.
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.
Key Features:
*Provides an in-depth discussion of recent advances in sterilization
*Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
*Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
*New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture |
| Note de contenu : |
.
Table of contents:
1-Why Validation?
2- Facility Design for Validation
3-Modular Facilities – Meeting the Need for Flexibility
4-Commissioning and Qualification
5- Design & Quaification of Controlled Environments
6- Validation of Pharmaceutical Water Systems
7- Validation of Critical Utilities
8- Calibration and Metrology
9- Risk Management and Thermal Validation
10- Change Control
11- MICROBIOLOGY OF STERILIZATION PROCESSES
12- Biological Indicators
13- Steam Sterilization in Autoclaves
14-Validation of Terminal Sterilization
15-Steam Sterilization-in-Place Technology and Validation
16- Dry Heat Sterilization
17- Depyrogenation by Inactivation and Removal
18- Ethylene Oxide Sterilization
19- Validation of chlorine dioxide Sterilization
20- Liquid Phase Sterilization
21- Vapor Sterilization and Decontamination
22- Validation of the Radiation Sterilization of Pharmaceuticals
23- Validation of Sterilizing Grade Filters
24-Disinfecting Agents: The Art of Disinfection
25- Cleaning and Disinfecting Laminar Flow Workstations, Bio Safety Cabinets and Fume Hoods
26- Contamination Control for Component Introduction to Classified Areas
27- Aseptic Processing for Dosage Form Manufacture
28-Validation of Manual Aseptic Processes
29- Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals
30-Qualification and Validation of Advanced Aseptic Processing Technologies
31-Total Particle Monitoring
32- Environmental Monitoring
33-Validation of Container Component Preparation
34-Validation of Lyophilization
35-Validation of Packaging Processes for Sterile Products
36-Levine
37- Validation of Active Pharmaceutical Ingredients
38-Cell Culture Process Validation including Cell Bank Qualification
39- Validation of Recovery and Purification Processes
40- Validation of Process Chromatography
41- Single Use Technologies and Systems
42- Considerations for Process Validation for Cell and Gene Therapies
43-Validation of Solid Dosage Forms
44- Validation of Validation of Oral / Topical Liquids & Semi-Solids
45-Validation of Non-Sterile Packaging Operations
46-Validation of Cleaning Processes
47-Validation of Training
48-Vendor Qualification and Validation
49-Validation of Clinical Trial Manufacturing
50- Validation of New Products
51-Retrospective / Continuous Process Validation
52- Validation & 6 Sigma
53-Validation and Contract Manufacturing
54-Computerized Systems Validation
55-Risk Based Validation of Laboratory Information Management Systems
56- Control Systems Validation
57-Process Analytical Technology and Validation
58-Validation of Analytical Procedures and Physical Methods
59- Validation of Microbial Methods
60-"Rapid Methods for Aseptic Processing and Their Validation"
61-Extractables and Leachables in Drug Products: An Overview
62-Evolution and Implementation of Validation in the United States
63- Validation in Europe - What are the Differences?
64-Japanese Approach to Validation |
| En ligne : |
https://images.routledge.com/common/jackets/crclarge/978036775/9780367756062.jpg |
Handbook of validation in pharmaceutical processes [texte imprimé] / James Agalloco, Auteur ; Phil Desantis, Auteur . - [S.l.] : CRC Presse, 2022 . - 1043p. : ill. ; 28cm x 22m. ISBN : 978-0-367-75606-2 Langues : Anglais ( eng) Langues originales : Anglais ( eng)
| Index. décimale : |
615 Pharlacikigue et thérapeutique |
| Résumé : |
.
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.
Key Features:
*Provides an in-depth discussion of recent advances in sterilization
*Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
*Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
*New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture |
| Note de contenu : |
.
Table of contents:
1-Why Validation?
2- Facility Design for Validation
3-Modular Facilities – Meeting the Need for Flexibility
4-Commissioning and Qualification
5- Design & Quaification of Controlled Environments
6- Validation of Pharmaceutical Water Systems
7- Validation of Critical Utilities
8- Calibration and Metrology
9- Risk Management and Thermal Validation
10- Change Control
11- MICROBIOLOGY OF STERILIZATION PROCESSES
12- Biological Indicators
13- Steam Sterilization in Autoclaves
14-Validation of Terminal Sterilization
15-Steam Sterilization-in-Place Technology and Validation
16- Dry Heat Sterilization
17- Depyrogenation by Inactivation and Removal
18- Ethylene Oxide Sterilization
19- Validation of chlorine dioxide Sterilization
20- Liquid Phase Sterilization
21- Vapor Sterilization and Decontamination
22- Validation of the Radiation Sterilization of Pharmaceuticals
23- Validation of Sterilizing Grade Filters
24-Disinfecting Agents: The Art of Disinfection
25- Cleaning and Disinfecting Laminar Flow Workstations, Bio Safety Cabinets and Fume Hoods
26- Contamination Control for Component Introduction to Classified Areas
27- Aseptic Processing for Dosage Form Manufacture
28-Validation of Manual Aseptic Processes
29- Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals
30-Qualification and Validation of Advanced Aseptic Processing Technologies
31-Total Particle Monitoring
32- Environmental Monitoring
33-Validation of Container Component Preparation
34-Validation of Lyophilization
35-Validation of Packaging Processes for Sterile Products
36-Levine
37- Validation of Active Pharmaceutical Ingredients
38-Cell Culture Process Validation including Cell Bank Qualification
39- Validation of Recovery and Purification Processes
40- Validation of Process Chromatography
41- Single Use Technologies and Systems
42- Considerations for Process Validation for Cell and Gene Therapies
43-Validation of Solid Dosage Forms
44- Validation of Validation of Oral / Topical Liquids & Semi-Solids
45-Validation of Non-Sterile Packaging Operations
46-Validation of Cleaning Processes
47-Validation of Training
48-Vendor Qualification and Validation
49-Validation of Clinical Trial Manufacturing
50- Validation of New Products
51-Retrospective / Continuous Process Validation
52- Validation & 6 Sigma
53-Validation and Contract Manufacturing
54-Computerized Systems Validation
55-Risk Based Validation of Laboratory Information Management Systems
56- Control Systems Validation
57-Process Analytical Technology and Validation
58-Validation of Analytical Procedures and Physical Methods
59- Validation of Microbial Methods
60-"Rapid Methods for Aseptic Processing and Their Validation"
61-Extractables and Leachables in Drug Products: An Overview
62-Evolution and Implementation of Validation in the United States
63- Validation in Europe - What are the Differences?
64-Japanese Approach to Validation |
| En ligne : |
https://images.routledge.com/common/jackets/crclarge/978036775/9780367756062.jpg |
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