Traceability:
At Shengshi Bio, we are committed to the continuous improvement of quality assurance. Our robust QA system is integrated into our products, starting from the cultivation, growth, and harvest of medicinal plants. Every stage of the manufacturing process strictly adheres to GMP and HACCP standards, with extensive testing conducted at each step of production. Given the complex nature of various products, maintaining the quality and reproducibility of their ingredients presents an ongoing challenge for manufacturers. Shengshi Bio guarantees the quality and consistency of the extract components, covering dozens of steps from raw material sourcing to the final product, ensuring that every phase of production meets high standards.
Shop
Raw Material Procurement：
We strictly select cultivated and wild-harvested plant materials according to the guidelines set by GACP. Once selected materials arrive at our facilities, they are stored in various standard warehouses under optimal conditions to preserve the integrity of the active ingredients. We conduct comprehensive testing of plant materials in accordance with international regulations and pharmacopoeias, including:
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- Origin Determination: The quality of the raw materials is a critical prerequisite because it influences all subsequent stages of production. Therefore, from these early steps, we apply GMP to ensure the quality of the final product.
- Supplier Inspection and Qualification: We perform thorough checks and qualifications of our suppliers in accordance with GACP guidelines.
- Selection of Plant Growth Areas: Choosing suitable regions for plant cultivation is essential to ensuring optimal quality.
- Control of Harvesting Period and Methods: We regulate the timing and methods of harvesting, along with the drying and storage conditions to maintain product integrity.
- Botanical Identification of Plants: Each plant and its parts are carefully identified to ensure authenticity.
- Quarantine of Biomass under Monitored Conditions: Raw plant materials undergo quarantine to ensure they meet the necessary quality standards.
- Contaminant Control: This includes testing for pesticides, aflatoxins, heavy metals, and microbial contamination.
- Active Ingredient Analysis: We perform detailed analysis to ensure the active ingredients meet quality expectations.
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Laboratory
Strict Controls to Prevent Errors：
The entire production process strictly adheres to GMP standards. Critical manufacturing steps have clear procedures and analyses in place. All raw data is recorded, and every key procedure and parameter is thoroughly detailed for workers, with double-checking in each batch record. The manufacturing process includes the following controls:
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- Grinding: Ensuring uniformity and quality of raw material size.
- Extraction Process: This involves the use of solvents, and strict control over extraction parameters such as time, temperature, and pressure.
- Concentration and Evaporation: These steps are carefully monitored to ensure efficiency and product consistency.
- Purification: Further refinement of the extract to ensure purity and quality.
- Drying: Ensuring moisture content is within acceptable limits to maintain stability.
- Packaging and Labeling: Proper packaging and labeling to maintain integrity and provide accurate product information.
- Metal Detection: Ensuring that products are free of harmful metals.
- Cleaning: Routine cleaning protocols are followed to avoid cross-contamination.
Test equipment
Finished Product Release: Inspection and Re-Inspection:
We cooperate with third-party CNAS laboratories for testing. Using qualified analytical reference standards, all data is compiled in the analysis certificate. We retain all original data for traceability of every batch, ensuring that we can trace any product when necessary. The final stage includes quality assurance/control reviews, which involve:
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- Batch Record Review: Ensuring compliance with established standards.
- Analysis Control: Verification of the content of active ingredients, impurities, heavy metals, pesticides, residual solvents, etc.
- Physical Analysis: Evaluating physical properties such as appearance, texture, and other relevant parameters.
- Microbial Analysis: Ensuring the product is free of harmful microorganisms.
By implementing these stringent controls and adhering to international standards, Shengshi Bio ensures that all products meet the highest quality and safety standards.
