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Our company's quality control system is a key part to ensure product quality and safety, and mainly includes the following Several aspects:
Quality Management System Establishment
Establish and implement a quality management system that complies with international standards to ensure that all production and R&D activities are conducted under a strict quality control framework.
Establish a quality management department and a full-time quality manager responsible for formulating, implementing and supervising quality management procedures.
Raw Material Procurement and Control
Ensure the procurement of raw materials and chemicals that meet standards and establish supplier evaluation and audit procedures.
Strict receiving inspection is conducted on each batch of raw materials to ensure compliance with specified quality standards and purity requirements.
inspection report
Sodium chloride detection
Sodium bicarbonate detection
Glacial acetic acid detection
Production Process Control
Develop detailed production processes and operating procedures to ensure that every production step can be traced and controlled.
Implement real-time monitoring and recording of key parameters during the production process, such as temperature, pH value, concentration, etc., to ensure product quality stability.
Product Testing and Verification
Develop and validate applicable test methods and inspection procedures, including physical property testing, chemical composition analysis, microbiological testing, etc.
Each batch of dialysate produced is comprehensively tested and verified, and each package produced is strictly tested to ensure that the product meets the specified specifications and performance requirements. Strict testing is carried out on every package produced
inspection report
Hemodialysis A fluid testing
Hemodialysis B fluid test
Product packaging inspection
Record and Document Management
Establish a complete record and file management system, including production records, quality inspection reports, quality incident records, etc.
All records must be complete, accurate, and traceable to specific production batches and operators.
Continuous Improvement and Failure Analysis
Implement continuous improvement measures to identify and correct potential quality problems through internal audits, management reviews and customer feedback.
Conduct root cause analysis of quality incidents and take corrective and preventive measures to prevent similar problems from happening again.
inspection report
Regulatory Compliance and Certification
Ensure that all products and quality management activities of our company comply with national and international regulatory requirements, such as FDA, CE certification, etc.
Timely update and comply with relevant laws, regulations and standard requirements to ensure market access and legality of products.
In 2002, it passed the GB/T19001 (ISO9001) quality system certification and YY/T0287 (ISO13485) certification, and is a well-known brand product in the same industry.
Our company's quality control system ensures that the dialysate products produced have stable quality and safety through strict management and monitoring measures to protect the health and therapeutic effects of dialysis patients.
Composed of pure cotton non-woven fabric, double long-chain quaternary ammonium salts and purified water. The active ingredient is didecyldimethylammonium chloride, with a content of 0.28-0.32%.
Hemodialysis Concentrate/Substance
Hebei Ziweishan Pharmaceutical provides a variety of formulas of hemodialysis concentrates, including high-calcium, low-calcium, high-potassium, and sugar-containing formulas, which meet ultra-pure dialysate standards and are suitable for a variety of dialysis machine models to meet the individual needs of different patients. Safe and stable, welco
Hemodialysis Powder Concentrate
Hebei Ziweishan Pharmaceutical provides high-purity hemodialysis concentrated powder, which complies with GMP standards, has few impurities, high safety, low acetate content, and is suitable for long-term dialysis and concentration For liquid use. To meet the efficient and safe dialysis needs of medical institutions across the country, consultation
