Our validation team provides customized service throughout the product life cycle
Our validation team provides customized service throughout the product life cycle
Based on the regulatory requirements of NMPA, EMA and FDA, by using tools like risk assessment, we develop process validation strategies for upstream, downstream and formulation process. We offer best validation service for customers at different stages to ensure the process is continuously under control.
We have good relations with cross border transportation agencies, first-class analytical device and instrument, and extensive experience in shipping validation. We propose appropriate shipment according to product storage condition as season changes to ensure product safety.
Qualification and validation of methods: spectrophotometry, HPLC, capillary electrophoresis, content determination, bio-assay, western blot, DNA residue, HCP residue, bioactivity/titer assay, microbiological to prove that the method conforms with corresponding requirements and ensure the accuracy of test results.
We are committed to perform customized drug compatibility study in compliance with the best research practice (characterization, simulation, leachables) recommended by PQRI. ICP-MS, GC-MS and other methods are used to detect the content of metal and concerned substances in simulated extraction experiment, migration and adsorption experiment under different environmental conditions.
We delegate validation work to competent organizations in compliance with CDE and ICH Q5A (R1) requirements. The validation of virus clearance targets multiple purification process (low pH treatment, affinity chromatography, anion chromatography, hydrophobic chromatography, cationic chromatography, virus removal nanofiltration).
Test and release of raw material, auxiliary material, culture media, packaging material, single use consumables, resin, and process media for clinical use and commercial projects as ChP, EP and USP required,. Methods include: appearance, pH, osmotic pressure, conductivity, solubility, relative density, viscosity, specific rotation, moisture, refraction, infrared absorption spectrophotometry, HPLC, bacterial endotoxin, microbial limit, sterility, growth promotion test.
We perform reasonably designed stability study to accommodate customer’s need. The long-term stability study, and study under accelerated conditions and study under influence factors will be carried out in strict accordance with the defined program. We also conduct trend analysis and generate report.
We built a quality system to ensure compliance with NMPA, EMA, FDA, WHO and ICH Q7 requirements. Our documentation system concerns personnel, utilities & facilities, equipment, materials and products, qualification and validation, documentation and quality management, contract manufacturing and analysi. Our quality management team is made up of experts, who know GMP requirements of EU, WHO, FDA, NMPA very well and once served in multinational biopharma companies and local drug authority and have extensive experience in GMP certifications at home and abroad.
