SciAnda (Changshu) follows the latest international(include the USA, EU and Japan) guidelines on cGMP and the requirements of the new Chinese GMP. The company continues to improve product quality and qualitysystems to match governmental and customer expectations and requests.
Quality Assurance
The Quality Assurance Department is responsible for all issues related to product quality. The function of this department is to set up systems and procedures to establish product quality and to set the standards that allow the quality control department to focus on the final testing of the products ensuring that the products conform to all specifications.The quality assurance systems and procedures are designed to ensure compliance with the company’s general operational philosophy with emphasis on how to operate in conformance with cGMP guidelines. In addition, it details how to achieve overall compliance with standard operational procedures, and how to ensure the execution of each process step and how responsibilities are defined. In orderto further enhance the understanding of cGMPs, the department routinely provides this type of training for the staff.
Quality Control
The Quality Control Department is responsible for specification compliance testing for all samples, including raw materials, starting materials, process intermediates, and final products. Every intermediateor finished product is monitored during the manufacturing process to ensure quality. The Quality Control Department is also responsible for the monitoring of water systems and the ambient production environment in order to control the quantity of micro particulates and microbials in the facility. In addition, the Quality Control Department manages the storage conditions for intermediates and finished products to ensure conformance with ICH guidelines for every product batch, and performs stability studies in a stability chamber. The department is composed of well educated and trained chemical specialists. All laboratories, including the microbial laboratory, are equipped with multi-purpose highly automated and high performance instruments. This department also manages the administration and coordination of stability study protocols, as well as the execution of scheduled annual product reviews.