New Standards, New Methods, New Technologies: Interpretation Training on Quality Control and Testing Standards of the 2025 Chinese Pharmacopoeia
On November 27, 2024, the Plenary Session of the Executive Committee of the 12th Chinese Pharmacopoeia Commission was convened in Beijing, where it reviewed and approved the draft of the 2025 edition of the Pharmacopoeia of the People’s Republic of China. The official release is scheduled for March 2025. This marks a brand-new milestone in China’s pharmaceutical sector and serves as a pivotal turning point for the enhancement of industry standards and quality.The promulgation and implementation of the new edition of the Pharmacopoeia will build a stronger “protective wall” for public medication safety, provide a clearer “compass” for promoting high-quality development of the pharmaceutical industry, and establish a more convenient “new bridge” for Chinese drugs to go global.
However, at present, although many pharmaceutical companies are well aware of the need to rapidly adapt to new standards, enhance quality management levels, gain precise insights into the latest changes in quality control and testing standards, and strategically plan their corporate development directions in advance, they remain stuck at the stage of theoretical discussion, lacking practical and effective action plans. In production practice, due to an inability to accurately grasp the details of the standards, these companies frequently encounter obstacles in quality control and production processes, thereby missing out on critical opportunities for development.
For this very reason, there is an urgent need for training that can “hands-on” address the practical challenges faced by enterprises.In response to the urgent needs of the industry,The Xi'an Pharmaceutical Association, in collaboration with Suzhou Danhuang Technology Co., Ltd. and Beijing Chengfeng Jihai Technology Co., Ltd., held an event in Xi'an on March 11–12, 2025.Co-hosted by[New Standards, New Methods, and New Technologies: Training on the Interpretation of Quality Control and Testing Standards in the 2025 Edition of the Chinese Pharmacopoeia] As the first targeted training event in the industry ahead of the imminent release of the 2025 Edition of the Chinese Pharmacopoeia, the organizers have specially invited renowned experts well-versed in domestic and international drug R&D analysis and production testing to share their extensive experience and case studies accumulated over many years in this field.
3．Aligning Domestic Drug Testing Methods and Manufacturing Processes with International Standards
4. Focusing on the Practical Application Effects of New Standards, Methods, and Technologies in Relevant Testing and Analytical Instruments
I.Specialists in quality management (QA&QC), R&D, and analysis at domestic pharmaceutical enterprises, R&D companies, CROs, universities, research institutes, and companies involved in the production and use of active pharmaceutical ingredients (APIs), pharmaceutical excipients, and pharmaceutical packaging materials, covering biological, biochemical, physicochemical, and traditional Chinese medicine sectors.
II.Relevant personnel from provincial drug evaluation centers, GMP audit and inspection departments, and provincial drug testing institutes (centers)
II. Brief Analysis of Traditional Chinese Medicine Standards and Changes in the 2025 Edition of the Pharmacopoeia
(1) Basic Principles for the Correct Use of the Chinese Pharmacopoeia — General Notices
（2）Changes in Traditional Chinese Medicines in the New Edition of the Pharmacopoeia
（3）General Rules for the Examination of Medicinal Materials and Decoction Pieces in the New Edition of the Pharmacopoeia
(4) General Technical Requirements — Pesticide Residues, Mycotoxins,Plant Growth RegulatorsResidue Assay
III. Analysis of the Current Status of Domestic and International Technical Guidelines for Analytical Method Development
IV. Challenges in the Bacterial Endotoxin Test for Injections and Research on Alternative Methods
(1) Challenges Facing Bacterial Endotoxin Testing — Limulus Resource Shortages, Special Sample Pretreatment, and Low Endotoxin Recovery
(2) Research on Alternative Methods — Recombinant Factor C Assay
(3) Research on Alternative Methods — Monocyte Activation Test (MAT)
(4) Research on Alternative Methods — Micro Limulus Amebocyte Lysate (LAL) Test
(5) Research on Alternative Methods — Reporter Gene Assay
V. Automation Technology for Bacterial Endotoxin Gel-Clot Assay
(1) Development History of Bacterial Endotoxin Testing Technology
(2) Technical Principles of Automating the Gel Method
(3) Composition of the Equipment System for Fully Automated Gel Method Testing
(4) Data Integrity andLIMS SystemConnection
(5) Experimental Validation and Data Comparison
(6) The Leap from Purely Manual to Automated
VI. Quality Control and Testing of Limulus Amebocyte Lysate (LAL) Reagent-Related Products
（1）Overview of Horseshoe Crabs: Scientific Value and Species Introduction
（2）Tracing the Origins of Limulus Amebocyte Lysate Research
（3）Development and Application of Specific Limulus Amebocyte Lysate Reagent
（4）ImpactLimulus Amebocyte Lysate (LAL) TestAnalysis of Factors Influencing Outcome Assessment
VII. Analysis of Key Points in Quality Control for Imported and Exported Drugs
VIII. New Standards and Heights in International Drug Development—Interpretation of Quality Control in Overseas Drug Development Phases
(1) Quality by Design in drug development is the determining factor for quality, encompassing product manufacturing, compliance, and clinical outcomes
(2) Emphasis on Quality in Product R&D Across Countries and Decision Trees
(3) Case Studies on How Different R&D Stages and Dosage Forms of Innovative Drugs Affect Quality
IX. Enhancing Drug Quality for Global Markets Through Post-Approval Changes
X. Biochemical Drugs and Recombinant Hormones Related to Bioassays and Their Additions and Revisions in the ChP 2025 Edition
（1）Bioassay — Chp 2025 Edition Publicly Released
（2）Recombinant Human Growth Hormone and Its Revisions in ChP 2025 (Volume III)
（3）Bioassay of Recombinant Human Insulin
（4）Bioassay of Recombinant Human Follicle-Stimulating Hormone (FSH Drug)
（5）Chinese Pharmacopoeia 2025 Edition, Volume IV: Biological Assays
XI. Interpretation of Policies Related to Innovative Drugs in China
(1) Current Status of China's Pharmaceutical Industry Development
(2) Core Policies on Innovative Drugs in China and Their Interpretation
(3) Future Development Trends of Innovative Drugs in China
(4) Summary of Innovative Drugs Approved for Market Launch by the National Medical Products Administration in 2023–2024
Registration Fee: RMB 2,480 per person
Early Bird Price:RMB 2,280Payment due by February 28
Xi’an Pharmaceutical Association Joins Hands with Former Pharmacopoeia Committee Members and Quality Heads of Pharmaceutical Companies for Joint Attendance
The first wave of guest lineup is grandly revealed~
More guest information is being continuously updated~
Training Agenda
Participating Companies from Previous Events
(Listed in no particular order; swipe up or down to view)
Registration Fee: RMB 2,480 per person
Early Bird Price:2,280 yuan,Payment before February 28
I.Letter of Authorization
For this event, the Xi'an Pharmaceutical Association has commissioned the following enterprises:
Suzhou Danhuang Technology Co., Ltd.
Unified Social Credit Code: 91320594MABMWFAE0Q
Address: No. 118 Bada Street, Suzhou Industrial Park, Suzhou Area, China (Jiangsu) Pilot Free Trade ZoneNo. Suzhou News Building Room 710, Building 1
Effective December 26, 2024, as the legally authorized agent of our organization, the said agent’sThe scope of authorization is: to act on behalf of our organization in matters concerning [New Standards, New Methods, New Technologies—Interpretation Training on Quality Control and Testing Standards of the 2025 Edition of the Pharmacopoeia] All matters related to the Xi'an event, including but not limited to venue rental and catering arrangements,A series of tasks, including accommodation arrangements, expert recruitment, participant enrollment, and securing corporate sponsorships, within the authorized scopewithin the scope, carry out related detailed work.
II.Contact Information
Suzhou Danhuang Technology Co., Ltd. Planning Director Ying Erjia
Contact Number: 13439390341 (also for WeChat)
E-Mail：ying.ej@vcbeat.net
For more details and inquiries:
Please contact:Ying Erjia
Tel:13439390341 (WeChat)
E-Mail：ying.ej@vcbeat.net
Registration Fee: RMB 2,480 per person
Early Bird Price:2,280 yuan,Payment before February 28