The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.
Author(s): Kim Huynh-Ba (auth.), Kim Huynh-Ba (eds.)
Series: Biotechnology: Pharmaceutical Aspects XII
Edition: 1
Publisher: Springer-Verlag New York
Year: 2010
Language: English
Pages: 266
Tags: Pharmacology/Toxicology
Front Matter....Pages i-xix
Front Matter....Pages 1-1
Introduction....Pages 3-5
Front Matter....Pages 8-8
Regulatory Perspectives on Product Stability....Pages 9-13
Current International Harmonization Efforts....Pages 15-22
Update on the WHO Stability Guideline....Pages 23-28
Development of a Regional Guideline for the Eastern Mediterranean Region....Pages 29-35
The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India....Pages 37-44
Requirements for South East Asian Markets....Pages 45-50
The Role of USP Monographs in Stability Testing....Pages 51-60
Regulatory Requirements for Stability Testing of Generics....Pages 61-66
Stability Design for Consumer Healthcare Products....Pages 67-73
Challenges of Drug/Devices Pharmaceutical Products....Pages 75-83
Practical Challenges of Stability Testing of Nutraceutical Formulations....Pages 85-91
Setting Tolerances for Instrument Qualification USP Chapter <1058>....Pages 93-97
Front Matter....Pages 100-100
The Concept of Quality-by-Design....Pages 101-106
Forced Degradation and Its Relation to Real Time Drug Product Stability....Pages 107-116
Low Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and Quantitation....Pages 117-121
Stability of Repackaged Products....Pages 123-133
Packaging-Induced Interactions and Degradation....Pages 135-144
An Overview of Physical Stability of Pharmaceuticals....Pages 145-152
Stability of Split Tablets....Pages 153-160
Front Matter....Pages 100-100
Temperature Monitoring During Shipment and Storage....Pages 161-167
Introducing a Science-Based Quality by Design Concept to Analytical Methods Development....Pages 169-179
Front Matter....Pages 182-182
Optimizing Stability Data Package to Facilitate NDA/MAA Approval....Pages 183-194
Maximize Data for Post Approval Changes....Pages 195-201
Use of Statistics to Establish a Stability Trend: Matrixing....Pages 203-209
Setting Specifications for Drug Substances....Pages 211-220
Setting Specifications for Drug Products....Pages 221-228
Highlights of Investigating Out-of-Specifications Test Results....Pages 229-237
Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs....Pages 239-245
Building and Developing of Relationships with Third Party Laboratories....Pages 247-252
Outsourcing Stability Testing: A Tool for Resource and Risk Management....Pages 253-257
Back Matter....Pages 259-265
