Quality Control
Product Quality Management
Product quality management is a top priority at Reisch. We continuously improve every aspect of our quality control process by enhancing employee training, advancing testing technologies, and refining our inspection criteria to ensure that every batch meets customer requirements. Reisch’s operations strictly adhere to international quality management standards, and we have obtained the ISO9001:2015 certification from SGS.
Reisch boasts large-scale production facilities that offer custom manufacturing services. We comply with stringent cGMP standards, and all employees undergo formal cGMP training when they join the company. Regular cGMP training and assessments are conducted to ensure all products are manufactured by well-trained employees following prescribed procedures and steps.
The facility adheres to strict petrochemical design standards with robust safety systems like Siemens DGS, DCS, and SIS. Quality assurance is built into the design, aiming for 100% compliance and product qualification, in line with FDA, EMA, and NMPA certifications.
Every batch we dispatch comes with a detailed quality inspection sheet, including information such as batch number, product characteristics, purity, production date, expiration date, storage conditions, and analysis data. Our guiding documents are based on ICH Q7 Good Manufacturing Practice guidelines, and we use these documents to provide formal cGMP training for all relevant staff upon joining and on a regular basis.
Advanced Analytical Equipment
Comprehensive Chromatography and Metals Analysis Capabilities
Gas Chromatography Analysis: Reisch retains numerous results of residual solvent measurements. We offer vaporization method measurements along with general solution injection methods (packed columns or capillary columns), and also have headspace equipment to meet diverse analytical needs.
Liquid Chromatography Analysis: Using a corona detector (CAD), Reisch analyzes sugar groups that lack UV absorption and are insensitive to RI detection or quaternary ammonium salts. Additionally, we perform reliable qualitative analysis and identify chemical structures of trace impurities with LC-QTOF.
Trace Metal Analysis: Reisch meets metal analysis requests with various specialized equipment. We can measure trace metals at the parts per billion (ppb) level, ensuring that customers receive the highest quality materials available.
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