New Standards, Methods & Technologies: Interpretation Training on Quality Control and Testing Standards of the 2025 Chinese Pharmacopoeia

Feb 06, 2025 13:38 CST Updated 13:38

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In May 2024, Hengrui Medicine received an FDA Form 483 due to deficiencies identified during an inspection of its manufacturing facilities, which hindered the U.S. marketing approval application for its PD-1 combination therapy. This incident served as a wake-up call for the entire industry regarding quality assurance (QA) and quality control (QC). The inspection standards of the FDA and the European Medicines Agency (EMA) are extremely stringent, encompassing comprehensive requirements such as production environment, equipment maintenance, document management, and data integrity. Industry cases demonstrate that merely making partial adjustments to document management software or revising procedures is no longer sufficient to meet international regulatory requirements; companies must conduct thorough assessments and implement systematic corrective actions.

Against the backdrop of accelerating internationalization of domestically produced pharmaceuticals, Chinese enterprises urgently need to align with the highest global standards, starting from every detail of the production process, to drive technological upgrades, equipment renewal, and the international transformation of quality management concepts. The release of the 2025 edition of the Pharmacopoeia presents a golden opportunity for companies to enhance their quality control and testing capabilities!

The 2025 edition of the Chinese Pharmacopoeia has introduced numerous updates in quality control and testing standards, such asSeveral general test methods have been added and revised, including spectroscopic analysis and chromatography. Meanwhile, new guidelines have been introduced for the control of visible particles in injections and for the evaluation of spray characteristics of inhalation and nasal preparations. Furthermore, the Pharmacopoeia has improved its microbial control system by adding several microbial-related drafts, such as tests for microbial limits, sterility, and bacterial endotoxins, to align with the development of international pharmacopoeial standards and regulatory requirements.

In response to the urgent needs of the industry, to precisely and effectively enhance the internationalization of quality standards for domestically produced products,The Xi'an Pharmaceutical Association, in collaboration with Suzhou Danhuang Technology Co., Ltd. and Beijing Chengfeng Jihai Technology Co., Ltd., jointly hosted the [New Standards, New Methods, New Technologies: Interpretation Training on Quality Control and Testing Standards of the 2025 Edition of the Chinese Pharmacopoeia] in Xi'an on March 11–12, 2025.Authoritative experts and enterprises well-versed in domestic and international requirements for drug research and development, testing, and regulatory submission will be specially invited., sharing with everyone the wealth of experience and case studies accumulated in this field over the years.

In this era of competition in drug quality and efficacy, as well as global community engagement, this training will continueDedicated to clarifying complex testing standards and mastering international market rules, we focus on sharing best practices in quality control and testing standards to help Chinese enterprises enhance their products’ competitiveness in the global market.

Training Objectives and Positioning

I. Subject

1. Focusing on Chinese pharmaceutical companies’ overseas product expansion businessQuality Control and Implementation

2. Focusing on Chinese pharmaceutical companies’ overseas expansion of their productsTesting Standards and Applications

3. Focusing on Relevant Testing and Analytical InstrumentsPractical Applications and Effect Demonstration

II. Positioning

1. Enhance the quality of domestically produced pharmaceuticals for export

2. Leading or aligning with international testing standards and methodologies

3. Demonstrating the Capability and Grade of China’s “Chip” Manufacturing

Training Overview

Training Name:New Standards, New Methods, New Technologies: Training on the Interpretation of Quality Control and Testing Standards in the 2025 Edition of the Pharmacopoeia

Training Time:March 11–12, 2025

Training Scale:100 people

Training Venue:Xi'an Hotel, 2nd Floor, Yannian Pavilion

Organizer:Xi'an Pharmaceutical Association

Organizer:Suzhou Danhuang Technology Co., Ltd., Beijing Chengfeng Jihai Technology Co., Ltd.

To register, please scan the QR code below:

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Registration Fee: CNY 2,480 per person

New Year Special Offer: ¥2,025Payment before February 12 (the 15th day of the first lunar month)

Early Bird Price:RMB 2,280Payment due by February 28

Xi'an Pharmaceutical Association Joins Hands with Multiple Former Pharmacopoeia Committee Members and Quality Heads of Pharmaceutical Companies to Attend Together

The First Wave of Guest Lineup Grandly Unveiled~

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More guest information is being updated continuously~

Training Agenda

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To register, please scan the QR code below:

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Registration Fee: RMB 2,480 per person

Spring Festival Special: 2025 Yuan,Payment before February 12 (the 15th day of the first lunar month)

Early Bird Price:RMB 2,280Payment before February 28

All regional stations across China are currently in the planning and preparation stages for 2025. The confirmed cities include:Beijing, Suzhou, Fuzhou...Other sub-sites and specific schedules are being updated continuously...

For more details and inquiries:

Please contact:Ying Erjia

Phone:13439390341 (WeChat)

E-Mail：ying.ej@vcbeat.net

Below is the notice from the Xi'an Pharmaceutical Association granting approval for this event, hereby released!

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