Recently, Laviana Pharma Cangzhou GMP production center successfully passed the ISO 9001:2015 Quality Management System Certification. The certification marks that the Laviana Pharma Cangzhou GMP production center has entered the track of enterprise management featuring standardization, programming, and normalization. It also means the production center has reached the international standard in terms of quality management system, which provides a strong guarantee for the sustainable development.
ISO 9001:2015 is a quality management system standard issued by the International Organization for Standardization (ISO), which aims to help enterprises lift product quality, enhance customer satisfaction, and improve enterprise management. During the 3 days of certification, the quality management system of the production center had been throughly analyzed and improved in strict accordance with the ISO 9001:2015 requirement.
During the audit, the audit experts conducted a rigorous analysis and audit of the implementation of the quality management system of Laviana Pharma. The audit team meticulously reviewed the system document, training material from Human Resources Department through on-site reporting, document checking and sample-picking. The audit results showed that the quality management system of the Cangzhou GMP production center was running well and met the requirements of the ISO 9001:2015 standard.
After this certification, Laviana Pharma will further improve its service level and provide customers with more reliable and high-quality one-stop CDMO services. Laviana Pharma will continue to optimize the management system, and make efforts in further improvement and innovation to meet customer needs and expectations. Thanks to our customers' support and trust, we will continue to work hard to ensure the stability and reliability of product quality and provide premium services to customers around the world.
The Cangzhou GMP production center, located in Lingang Economic and Technological Development Zone, Cangzhou City, Hebei Province, boasts with 12 independent production line workshops and a high-pressure hydrogenation production line, two of which can undertake OEB4 level projects. The total reaction volume of the equipment is about 106,700 L, and it is equipped with high active material production equipment with protection level OEL1-10ug/m³. The company also has an independent 3,400 m2 quality control laboratory, equipped with the major chromatographic, spectral, box and other experimental equipment. In terms of hazardous waste treatment, the company has outsourced the business with a design capacity of 1,738 tons/year and an approved capacity of 1,738 tons/year, which has a great advantage in Lingang Chemical Industry Zone.
In terms of wastewater treatment, the wastewater design capacity is 500 tons/day, covering phase 1 process wastewater, public engineering drainage, domestic sewage and other systems, and the total volume of the water treatment system is more than 5,400 cubic meters. In terms of waste gas treatment, the company owns Regenerative Thermal Oxidizer (RTO) treatment device with a processing capacity of 10,000 m3/h. The processing capacity of the workshop waste gas treatment system is 36,000 m3/h, warehouse 44,000 m3/h, quality inspection building 20,000 m3/h, water treatment 10,000 m3/h. The total treatment capacity of exhaust gas reaches 120,000 m3/h.