Active Pharmaceutical Ingredients : Development, Manufacturing, and Regulation, Second Edition
Safety, efficacy, and environmental/regulatory requirements
Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China
The FDA's intensified foreign inspection program
Multi-use and flexible design facilities
The shift from maintenance scheduling to built-in reliability
This second edition focuses on the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the United States and international regulatory agencies.
- Hardback | 456 pages
- 152 x 229 x 25.4mm | 771g
- 18 Dec 2009
- Taylor & Francis Inc
- CRC Press Inc
- Bosa Roca, United States
- New edition
- 2nd New edition
- 35 Illustrations, black and white
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Table of contents
Introduction, Stanley H. Nusim
Consolidation and Integration
Computer Control and Automation
Bulk Drugs: The Process Development Task, Carlos B. Rosas
The Bulk Drug Process as Part of the Drug Development Program
From the Bench to the Pilot Plant and Beyond
The Physicochemical Attributes of the Bulk Drug
The Process Body of Knowledge
New Trends and Their Probable Impact on Bulk Drug Process Development
Processing Responsibility in Bulk Drug Process Development
Outsourcing in Bulk Drug Process Development
Bulk Drugs: Process Design, Technology Transfer, and First Manufacture, Carlos B. Rosas
The Process Design Task in Bulk Drugs
Technology Transfer of the Bulk Drug Process and First Manufacture
In Closing-The Processing Technologies of Bulk Drugs
Design and Construction of API Manufacturing Facilities, Steven Mongiardo
Project Scope Development
Preliminary Scope Development
Safety and Environmental Considerations
Design Strategy and Detailed Design
Sterile Process Facilities Design
Regulatory Affairs: Requirements and Expectations, John Curran
High-Level Requirements for Submission of Regulatory CMC Documents
Contents of Regulatory Submissions-API Sections
The Review and Approval Process
Postapproval Change Evaluations
Regulatory Affairs: Guidelines, Evolving Strategies, and Issues, John Curran
Guidelines Issued by the International Conference on Harmonisation
Regulatory Agency Guidelines
Evolving Strategies and Issues
Validation of Active Pharmaceutical Ingredients, James Agalloco and Phil DeSantis
Definition of Validation
Application of Validation
Life Cycle Model
Validation of New Products
Validation of Existing Products
Bulk Pharmaceutical Chemical Validation
Procedures and Personnel
Validation of Sterile Bulk Production
Quality of Active Pharmaceutical Ingredients, Michael C. Vander Zwan and Carlos Yuraszeck
The Quality Management Department
The Regulatory Authorities
Part I: Defining and Ensuring the Quality of the Active Pharmaceutical Ingredient
Part II: The Regulations for Quality
Q7 Section I: ``Introduction''
Q7 Section 2: ``Quality Management''
Q7 Section 3: ``Personnel''
Q7 Section 4: ``Buildings and Facilities''
Q7 Section 5: ``Process Equipment''
Q7 Section 6: ``Documents and Records''
Q7 Section 7: ``Materials Management''
Q7 Section 8: ``Production and In-Process Controls''
Q7 Section 9: ``Packaging and Identification Labeling of APIs and Intermediates''
Q7 Section 10: ``Storage and Distribution''
Q7 Section 11: ``Laboratory Controls''
Q7 Section 12: ``Validation''
Q7 Section 13: ``Change Control''
Q7 Section 14: ``Rejection and Reuse of Materials''
Q7 Section 15: ``Complaints and Recalls''
Q7 Section 16: ``Contract Manufacturers (Including Laboratories)''
Q7 Section 19: ``APIS for Use in Clinical Trials''
Part III. The Quality Control and Quality Assurance Department
Environmental Control, Bruce Wallington
License to Operate
Environmental Management Systems
Permit Project Schedules
Applicable Regulatory Requirements
Control Equipment Plan
Management of Change
Green Chemistry Initiatives
Thermochemical Process Safety-An Introduction, Carlos B. Rosas
Hazards, Risks, and Consequences-Definitions and an Actual Thermochemical Example
Thermochemical Events and Their Basis-Energy
Thermochemistry, Heat Effects in Chemical Reaction Processing, and Calorimetry
Thermochemical Hazards and Their Assessment
Exothermic Reactions-Runaways and Unintended Reactions
Thermochemical Hazard Avoidance, Prevention, and Risk Reduction
Design and Operating Practices for Safety, Stanley S. Grossel
Flammable/Combustible Liquids Storage and Handling
Toxic Gas Storage and Handling
Cyanides Storage and Handling
Handling and Containment of APIs
Reactor Design and Operation
Presure Relief and Effluent Handling
Fire and Explosion Protection
Plant Operations, Stanley H. Nusim
Batch Versus Continuous Operations
Dedicated Versus Shared Manufacturing Facilities
Sterile Bulk Active Pharmaceutical Ingredient Production, James Agalloco and Phil DeSantis
Typical Sterile Bulk Active Pharmaceuticals Ingredients and Excipients
Sterile Synthesis Steps
Considerations for Sterile Bulk Pharmaceutical Chemical
Buildings and Facilities
Personnel Training and Qualification
Aseptic Processing Simulation
In-Process Sterilization of Bulk APIs and Excipients
Biological Production of Active Pharmaceutical Intermediates, Max J. Kennedy, Randolph L. Greasham, and Stephen W. Drew
Regulation of Microbial Metabolism and Product Formation
Reducing Variability and Throughput Time in Inoculum Development
Scale-Up to Manufacturing
Strategies for Process Development and Scale-Up of Biological Products
Production of a Recombinant Vaccine in Saccharomyces Cerevisiae
Triggering Immune Response
Estimates of Capital and Operating Costs for Manufacture from Fermentation or Cell Culture
Contract Manufacturers for API from Fermentation or Cell Culture
Contract Development Organizations and Contract Manufacturing Organizations for Fermentation and Cell Culture Biological Products
What Happens if the Fermentation or Cell Culture Does not Perform as You Expect?
Supply Management, Victor J. Catalano
Introduction to Supply Management
Equipment Maintenance and Reliability, Kaizad P. Sunavala
Strategic Plan (2)
Reliability Fundamentals Program