Our Quality Management Principles
1. Eliminate possibilities of contamination and cross-contamination; minimizing the possibilities of human error and operational mistakes.
From the design of plant facilities, the selection of equipment materials, the identification of process parameters, personnel training, on-site management, cleansing steps, review and validation, our quality department has developed highly efficient and stable management protocols and operating procedures. We also emphasize execution to minimize quality risk and enhance product quality.
2、 An effective validation management and implementation system.
We place great emphasis on the importance of validation, and have set up validation committee and validation implementation teams. Our validation system covers plant design, analytical instruments, equipments, test methods, production processes, cleansing operation and materials. The system comprehensively include design qualification (DQ), install qualification (IQ), operational qualification (OQ) and performance qualification (PQ), which permeates from research design, laboratory samples, scale up manufacturing to commercial batches. No major changes will be effected before validation and approval. Equipments and processes will not put into use before validation. These ensure effective production and stable product quality.
We intend to give our APIs higher quality standards then described in EP, USP or JP, paying special attention to analytical methods validation. We follow through FDA guidelines for analytical methods validation, including accuracy, precision (repeatability and precision intermediate), the nature of the detection limit, quantitative restrictions, linearity, range and durability. This is to ensure our data are accurate and reliable. Through these practices, we have accumulate lots of experiences towards our API assay, solvent residues and impurity analysis.