文档介绍：上海CMC详细培训EnsuringDrugQualityforPublicHealthTheImplementation
上海CMC培训-Ensuring-Drug-Quality-for-Public-Health-The-Implal Standard-Setting
Shifting Focus to Conduct More Pre-Approval Inspections
Utilizing Tools to Detect Counterfeiting
Supply Chain: Developing Tools and Standards for Tracking/ Tracing
*
China’s Role in Drug Development: Challenges for China
Need for Regulatory Reform
Uniformity of implementation of CGMP across all provinces
Regulatory Authorities Working to Strengthen Capacity, Authority, Streamline Reporting Structures
Counterfeits
Economically-Motivated Adulteration
“Show” and Shadow Factories
Supply Chain Integrity
Bulk Chemicals
Excipient Quality
Raw Material Processing Where There is no Oversight
Adverse Drug Reaction Reporting
Different Standards for Domestic, Exported Products
Data Integrity
Process Inspects Firms Generally, Not Capacity to Produce Specific Products
*
*
CGMP Requirements & Principles Issues of Most Concern
*
CGMP
C” = current dynamic and evolve over time
“GMP” = Good Manufacturing Practices
Minimal standards
Not “best” practices unless “best” is, in fact, current minimal.
*
Potential Problems from Non-Compliance with CGMP
Super-potency or Subpotency
Impurities
Contamination
Safety and Efficacy effects
*
Some Issues of most concern
Day-to-day implementation of CGMP
Understanding the product and the process
Can’t “test” quality into the product
Quality system management
Material management
Equipment qualification and use
Supply chain management
*
Day-to-day Implementation of CGMP
Eliminate variability
Achieving Process Consistency is of utmost importance to ensure quality of each batch
*
Process Understanding Inadequate Development Work
Reaction parameters are often too wide and not supported by development work
Either extremity of an executed range of parameters is often selected as optimal condition
Gaps in knowledge management in progressing from one stage to another stage
Lack of for