Quality Control Process
Our processes strictly adhere to Standard Operating Procedures (SOPs) that comply with the FDA’s Good Manufacturing Practices (GMPs). Our quality assurance practices begin with our ingredient suppliers, apply to all points in the manufacturing process, and culminate with finished product analysis and stability testing. For those outside suppliers that we have normally more than 20 years business cooperation.
Raw Material QC
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As one of initial procedures, our trained professional will visit supplier site
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Ingredient suppliers’ facilities & procedures are routinely audited by QA personnel
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Raw materials are placed in quarantine once received. Then they are sampled to test for purity, assayed for potency, and checked for identity.
In-Process QC
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Preparation: After raw materials are released, in-process checks are conducted at every stage of the manufacturing process to ensure consistent quality. Equipments are sanitized prior to use through validated cleaning methods to eliminate the risk of contaminants.
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Blending: Specialized sanitization of equipment is conducted to eliminate contaminants and to detect and remove traces of allergens.
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Compression and Encapsulation: A series of physical and chemical tests are conducted during set-up, and at regular intervals while batch is being produced. Depending on the dosage, several tests are conducted including:
A. Disintegration B. Weight variation C. Thickness D. Friability E. Metal detection
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Coating: Tablets and capsules are sampled for weight variation prior to, during, and after coating.
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Packaging: In-process samples are tested for fill criteria, torque parameters, aesthetics, and microbial contamination.
Finished Products QC
The goal of finished products QC is to ensure that all products and their ingredients meet physical criteria and are tested for their purity, strength, composition, identity, and quality.All finished products are tested for:
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Purity: Tests are conducted to detect the presence of contaminants, such as microbes and heavy metals.
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Strength: Those assays are built to establish the potency of active ingredients using validated methods.
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Composition: Tests are conducted to determine the composition of a product.
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Physical criteria: Test are conducted to assess the physical quality of a product, such as disintegration time, hardness, and weight variation