HumanwellCaps Successfully Hosts Company-wide CGMP Training

To fully implement the company's core “Product Leadership” strategy, accelerate its internationalization, and ensure the delivery of safe, high-quality products and services to a global clientele, Hubei Renfu Pharmaceutical Excipients Co., Ltd. successfully held a company-wide quality training session on April 27, 2024, focused on “cGMP Fundamentals.” The training was designed to systematically enhance quality awareness among all employees, solidify the foundation of quality management, and thereby improve operational efficiency and product quality while effectively mitigating potential risks and errors in the production process.

The company invited a senior expert in quality management from the industry to serve as the lead instructor, ensuring the professionalism and authority of the training content.

Leadership Sets the Course, Defining the Quality Vision

At the opening ceremony, Company Chairman Huang Jianhua delivered an important speech. He profoundly stated, “Quality is the lifeblood of an enterprise, and excellence is born from rigorous design and lean production.” He emphasized that advancing the FDA DMF filing process is not only a necessary step to meet the high standards of international clients but also a critical move to enhance the company’s core competitiveness. A quality system compliant with international standards must be integrated throughout the entire product lifecycle, from R&D to discontinuation. Chairman Huang encouraged every employee to recognize that they are a window and brand ambassador for the company. He urged everyone to embrace the philosophy that “training changes awareness, awareness changes behavior, and behavior changes performance.” He called on all staff to strictly adhere to cGMP regulations, consistently prioritize the customer, focus on creating value for them, and collectively propel the company to become a leader in the global pharmaceutical excipients market.

Substantive Content: Integrating Theory with Practice

The training curriculum was comprehensive and systematic, providing in-depth coverage of key domestic and international regulatory frameworks, including China GMP (2010 Edition), US FDA cGMP (21 CFR Parts 210 & 211), EU GMP, and ICH Q7. Key provisions were interpreted in detail with guidance on practical application. By incorporating vivid case studies relevant to the company’s actual operations, the instructor transformed abstract regulatory text into concrete, actionable guidance. Furthermore, the course highlighted commonly used and classic analytical tools and methods in quality management, enabling participants to build a solid theoretical framework while also gaining practical insights applicable to their daily work.

Interactive Engagement: Fostering a Consensus on Quality

Following the instructional sessions, an interactive Q&A took place, where the instructor provided detailed answers to questions from the attendees. To further solidify the training’s impact, the company immediately organized a “Management Insight Sharing Session.” Company leaders, department heads, and employee representatives gathered to share and discuss their key takeaways and reflections from the training. This exchange of ideas helped ensure that the principle of “Quality First” is not merely an empty slogan but is genuinely integrated into the mindset and actions of every employee. This has injected powerful internal momentum into the company’s continued pursuit of high-quality development.