Quality

Core cornerstone: GMP quality management system

This is the foundation of quality control and a mandatory legal requirement. GMP (Good Manufacturing Practice) is a set of mandatory standards applicable to the pharmaceutical and health food industries.

It requires:

• Factory buildings and facilities: The production environment must meet cleanliness requirements (such as D-level clean areas), have a reasonable layout, and effectively prevent cross contamination and confusion.
• Equipment: The equipment must be matched with production requirements, easy to clean, disinfect, and maintain, and regularly calibrated to ensure accurate operation.
• Personnel: All operators must undergo strict health checks and pre job training before they can take up their posts. Personnel in the quality management department need to possess corresponding professional knowledge.
• File management: 'Remember what you do'. All operations must have standard operating procedures (SOP), and all production and inspection activities must have clear and complete records to achieve full process traceability.

Simply put, a factory that has passed GMP certification has provided a guarantee for high-quality production from a hardware perspective.

Key points of quality control throughout the entire process

Quality control runs through every aspect of the product lifecycle

level 1: Raw material control (source assurance)

1. Supplier Management

Conduct strict on-site audits and qualification reviews of raw material suppliers, and establish a list of qualified suppliers.  
Do not purchase from suppliers with unknown sources or incomplete qualifications.

2. Incoming Inspection (IQC):

After each batch of raw materials arrives, the quality inspection department must take samples for inspection.  
Verify the COA (Composition Analysis Report) of the raw materials and test their appearance, purity, active ingredient content, microbial limits, heavy metals, and other indicators.  
Only after all are qualified can they be stored and used.

Level 2: Production Process Control (Core Link)

1. Pre feeding review: When receiving materials and weighing according to the formula, a second person must review to ensure 100% accuracy of the type and dosage.  
2. Process parameter control: Key parameters such as temperature, time, pressure, and stirring speed during the production process must be strictly executed in accordance with the process specifications and recorded in real-time.  
3. Intermediate Product Inspection (IPQC): Inspection is conducted during the semi-finished product stage (such as particle size, moisture content, tablet hardness, and brittleness) to promptly identify and correct problems and avoid waste.  
4. Clearance management: Before and after the production of different products and batches, the equipment and site must be thoroughly cleaned and inspected to prevent cross contamination and confusion. This is the top priority of GMP management.  
5. Environmental monitoring: Regularly monitor the air cleanliness (settling bacteria, suspended particles) of the production workshop, the hands of operators, workbenches, etc. for microorganisms to ensure that the production environment is continuously controlled.

Level 3: Finished product inspection (factory release)

1. Full inspection: Conduct a comprehensive inspection of all items required by national regulations and enterprise standards on the finished product, including:

Sensory indicators: color, odor, characteristics, taste.  
Physical and chemical indicators: moisture content, ash content, disintegration time, weight difference, etc.  
Content of active ingredients: Ensure that the content of active ingredients is not lower than the labeled value (which is the core of health food).  
Hygiene indicators: Microbial limits for total bacterial count, coliform bacteria, mold, yeast, and other microorganisms.  
Pollutant indicators: heavy metals such as lead, arsenic, mercury, and pesticide residues.

2. Release review: Only when all inspection items are qualified and the production records are complete and without deviation, can the Quality Authorized Person (QP) sign and approve the release of the product from the factory. Each batch of products should be accompanied by their own COA (Finished Product Inspection Report).

Level 4: Post listing and Traceability

1. Sample observation: Each batch of products must be sampled according to regulations, and stability tests must be conducted regularly to evaluate the quality changes during the shelf life and provide data support for determining the shelf life.  
2. Product traceability system: Establish a complete traceability chain from raw material batch number ->production batch number ->finished product batch number. If any quality issues occur in the market, they can be quickly traced back to the source of the problem and related products can be recalled.  
3. Stability testing: Accelerated testing and long-term testing are conducted during the product development stage to scientifically determine the shelf life of the product.

In summary, food quality control is a complex project that relies on "system driven, process guaranteed, and everyone's responsibility". It relies not on the "inspection" at the last checkpoint, but on the "prevention" and "guarantee" integrated into every link from raw materials to consumers' hands. Choosing a factory with strict quality management is the fundamental guarantee for product success.