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Active Pharmaceutical Ingredients
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Table of Contents

Preface
Contributors

Introduction, Stanley H. Nusim
Consolidation and Integration
Quality
Potency
Computer Control and Automation
Summary

Bulk Drugs: The Process Development Task,
Carlos B. Rosas
Introduction
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
In Closing
References

Bulk Drugs: Process Design, Technology Transfer, and First Manufacture,
Carlos B. Rosas
Introduction
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
References

Design and Construction of API Manufacturing Facilities,
Steven Mongiardo
Introduction
Project Scope Development
Preliminary Scope Development
GMP Considerations
Safety and Environmental Considerations
Design Strategy and Detailed Design
Design Development
Sterile Process Facilities Design
Construction Management
Conclusions
References

Regulatory Affairs: Requirements and Expectations,
John Curran
Introduction
High-Level Requirements for Submission of Regulatory CMC Documents
Contents of Regulatory Submissions-API Sections
Registration Samples
The Review and Approval Process
Preapproval Inspections
Postapproval Change Evaluations

Regulatory Affairs: Guidelines, Evolving Strategies, and Issues,
John Curran
Introduction
Guidelines Issued by the International Conference on Harmonisation
Regulatory Agency Guidelines
Evolving Strategies and Issues
The Future

Validation of Active Pharmaceutical Ingredients,
James Agalloco and Phil DeSantis
History
Definition of Validation
Regulations
Application of Validation
Life Cycle Model
Validation of New Products
Validation of Existing Products
Implementation
Bulk Pharmaceutical Chemical Validation
In-Process Controls
Cleaning Validation
Computerized Systems
Procedures and Personnel
Validation of Sterile Bulk Production
Conclusion
References

Quality of Active Pharmaceutical Ingredients,
Michael C. Vander Zwan and Carlos Yuraszeck
Introduction
The Product
The Process
The Facilities
The People
The Quality Management Department
The Regulatory Authorities
The Regulations
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
Introduction
License to Operate
Environmental Management Systems
Environmental Scoping
Permit Project Schedules
Environmental Profile
Environmental Dossier
Applicable Regulatory Requirements
Control Equipment Plan
Operational Flexibility
Management of Change
Sustainability
Green Chemistry Initiatives
Conclusions
References

Thermochemical Process Safety-An Introduction,
Carlos B. Rosas
Preamble
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
In Closing
References

Design and Operating Practices for Safety,
Stanley S. Grossel
Introduction
Flammable/Combustible Liquids Storage and Handling
Toxic Gas Storage and Handling
Water-Reactive Chemicals
Cyanides Storage and Handling
Handling and Containment of APIs
Reactor Design and Operation
Presure Relief and Effluent Handling
Fire and Explosion Protection
References

Plant Operations,
Stanley H. Nusim
Plant Organization
Batch Versus Continuous Operations
Dedicated Versus Shared Manufacturing Facilities
Shift Operations
Clean Room
Cost Control
Employee Safety

Sterile Bulk Active Pharmaceutical Ingredient Production,
James Agalloco and Phil DeSantis
Introduction
Typical Sterile Bulk Active Pharmaceuticals Ingredients and Excipients
Sterile Synthesis Steps
Considerations for Sterile Bulk Pharmaceutical Chemical
Buildings and Facilities
Personnel Training and Qualification
Container-Closure Systems
Time Limitations
Aseptic Processing Simulation
Sterilization
Laboratory Controls
Sterile Excipients
In-Process Sterilization of Bulk APIs and Excipients
Other Attributes
Conclusion
References

Biological Production of Active Pharmaceutical Intermediates,
Max J. Kennedy, Randolph L. Greasham, and Stephen W. Drew
Introduction
Microorganisms
Bioreactors
Fermentor Design
Regulation of Microbial Metabolism and Product Formation
Growth Media
Medium Components
Medium Sterilization
Growth Kinetics
Seed Train
Reducing Variability and Throughput Time in Inoculum Development
Downstream Processing
Solvent Processing
Scale-Up to Manufacturing
Strategies for Process Development and Scale-Up of Biological Products
Bioanalytics
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?
References

Supply Management,
Victor J. Catalano
Introduction to Supply Management
Production Planning
Inventory Management
Purchasing/Supply Management
Distribution/Transportation
Information Technology
Quality Management
Reference
Further Reading

Equipment Maintenance and Reliability,
Kaizad P. Sunavala
Introduction
Strategic Plan (2)
Reliability Fundamentals Program
Summary
References
Index

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