Qingdao Huaren Medical Product Co., Ltd, a leading manufacturer of pharmaceutical rubber stoppers dedicated to delivering high-quality packaging solutions for the global pharmaceutical industry, is proud to announce that it has officially obtained the ISO15378 certification. This prestigious certification is a testament to the company’s unwavering commitment to meeting and exceeding international quality management standards for primary pharmaceutical packaging materials, marking a significant milestone in its global development strategy.

ISO15378 is an internationally recognized standard specifically developed for the quality management systems of suppliers of primary pharmaceutical packaging materials. It integrates the requirements of ISO9001 with additional criteria tailored to the pharmaceutical industry, covering critical aspects such as raw material sourcing, production process control, cleanroom management, product traceability, and risk management. Achieving this certification requires rigorous assessment and verification by an authoritative third-party certification body, ensuring that the certified enterprise’s products and services fully comply with the strict quality and safety requirements of the global pharmaceutical market.

As a professional manufacturer of pharmaceutical rubber stoppers, Qingdao Huaren Medical Product Co., Ltd has always regarded product quality and safety as the cornerstone of its development. In the process of pursuing ISO15378 certification, the company has comprehensively optimized its quality management system, upgraded production equipment and cleanroom facilities, strengthened staff training on pharmaceutical GMP (Good Manufacturing Practices) requirements, and established a full-process quality control system from raw material inspection to finished product delivery. Every link of the production process is strictly monitored and recorded to ensure the stability, reliability, and safety of pharmaceutical rubber stoppers.

Pharmaceutical rubber stoppers are critical primary packaging materials that directly contact drugs, and their quality and safety are closely related to the stability and efficacy of drugs. With the ISO15378 certification, Qingdao Huaren Medical Product Co., Ltd’s pharmaceutical rubber stopper products will better meet the entry requirements of international markets such as Europe, America, and Asia, further expanding the company’s global market share and promoting the internationalization process of the brand.

For more information about Qingdao Huaren Medical Product Co., Ltd and its pharmaceutical rubber stopper products, please visit https://www.sinohrpp.com