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QUALITY ASSURANCE SYSTEM

Raw Material Control

Supplier screening: Strictly review the qualifications of raw material suppliers such as chitosan, assess their production and quality control capabilities, and only those who pass the evaluation can be included in the procurement list.
Incoming inspection: Inspect raw materials batch by batch, covering appearance, purity, key component content, etc. When testing chitosan, parameters such as deacetylation degree will be measured, and only after passing the test can it be put into production.

Standard Operating Procedures

Standard Operating Procedure (SOP): Develop detailed SOPs for various production processes such as feeding, reaction condition control (temperature, pressure, duration, etc.), and product post-processing to ensure standardized production. For example, in the production of hydroxypropyl chitosan, it is necessary to strictly follow the prescribed temperature,etc.

QUALITY CONTROL PROCESS

Quality Control Of Raw Materials

Supplier Screening

Qualification review: A professional team reviews the licenses and permits of raw material suppliers such as chitosan, considers industry experience, and selects enterprises with good reputation.
Field visit: Visit key suppliers, inspect workshop layout, equipment condition, and storage conditions, and evaluate the automation level of chitosan production equipment.
System evaluation: Review quality manuals and other documents, refer to internal audit and sampling records, and assess supplier quality control capabilities.

Incoming Inspection

Appearance: Quality inspectors inspect the color and clumping of chitosan, as well as the crystal morphology of azelaic acid and salicylic acid. Any abnormal raw materials are further inspected or rejected.
Purity: Use HPLC to measure the purity of the raw materials, and return any that do not meet the standards.
Indicator testing: Based on the characteristics of different raw materials, such as the degree of deacetylation of chitosan, chemical titration is used to ensure compliance before qualified raw materials can enter production.
Quality Monitoring Of Production Process

Standard Operating Procedure (SOP)

Operation guide: Develop operating standard procedures and clarify the feeding sequence.
Condition control: Strictly control the reaction temperature, pressure, and time to ensure stable reaction.
Post processing: Clarify the parameters such as the number of times the product is washed and dried, solvent, temperature, etc., and use low-temperature vacuum drying to ensure quality.

Equipment Maintenance

Daily cleaning: Operators clean the equipment before and after each shift, inspect the appearance and components.
Regular maintenance: Develop a plan, have professional personnel deeply maintain key equipment, and calibrate precision instruments.
Performance verification: Conduct regular trial production and determine whether the equipment needs to be adjusted based on product quality indicators.

Personnel Management

Skill training: Regularly conduct professional training on production processes, quality control, and invite experts to share technical methods.
Awareness enhancement: Enhance employees' quality awareness through training and posting slogans.
Operation supervision: Establish a supervision post to correct illegal operations and educate and assess personnel to ensure production follows SOP.
Finished Product Quality Inspection

Sampling Inspection

Online initial inspection: Set up real-time sampling points on the production line to inspect appearance, content, and other indicators before packaging.
Full inspection upon storage: Samples are taken according to standards, and physical, chemical, and microbiological indicators are comprehensively tested. Only those that pass the inspection can be stored.
Retain samples for retesting: Retain samples for each batch of finished products and conduct regular retesting to monitor quality stability.

Testing Items

Physical properties: Check appearance, particle size, density, etc. to ensure that the particle size of chitosan products meets application requirements.
Chemical properties: Analyze purity, acidity and alkalinity, and measure acidity and alkalinity using acid-base titration.
Microbial indicators: Strictly detect microbial indicators such as total bacterial count for specific field products.

Quality Assessment and Handling

Standard judgment: Determine whether the finished product is qualified based on enterprise and industry standards.
Handling of non-conforming products: isolate non-conforming products, record details, rework or scrap according to the situation, analyze the reasons and prevent recurrence.
Quality Traceability And Continuous Improvement

Quality Traceability System

Full process recording: from raw material procurement to finished product sales, record information at each stage.
Quick response: Enter the batch number to quickly query the problem process, recall and rectify in a timely manner.

Continuous Improvement Mechanism

Data collection and analysis: Regularly collect quality data and use statistical methods to identify problems.
Improvement measures formulated: Optimize process parameters for problems, and verify through small-scale and medium scale experiments.
Full participation: Encourage employees to provide suggestions, reward effective proposers, and conduct group activities to improve the system.

GMP WORKSHOP CERTIFICATION

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ISO 9001: 2015 Quality Management System Certificate
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ISO 14001: 2015 Environmental Management System Certificate
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ISO 45001: 2018 Occupational Health and Safety Management System

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Jinan Xinzhiyuan Biotechnology Co., Ltd. is a high-tech enterprise specializing in new materials, including pharmaceutical excipients and cosmetic ingredients, relying on the support of Shandong Binzhou Zhiyuan Biotechnology Co., Ltd.

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