Renpu(Suzhou)Pharmaceuticals Ltd.

Quality System

The quality management department is responsible for all quality management and quality testing of the whole production process. Quality management department consists of quality assurance department and quality control department. Quality assurance department is mainly responsible for establishing quality system, document system, qualification and validation, releasing material and product, batch record review, deviation investigation, change control, preventive measures and corrective measure, evaluation and approval of raw material and packaging material supplier, product quality review analysis, complaint and adverse reaction, internal and external audit etc. Quality control department is mainly responsible for testing of raw materials, packaging materials, semi-finished product and finished product, retention sample and stability test etc. Quality control department sets up the physical and chemical room, precise instrument room, microbial room, sample room, and other functional rooms, and is equipped with inductively coupled plasma, high performance liquid chromatography, gas chromatograph, ultraviolet spectrophotometer, refractometer etc.

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