|
Quality Method
|
Assay |
Specification |
|
Harvest and dry herbs
|
Grade herbs |
Visual Sorting |
Grade A |
|
|
Speciate herbs |
Visual, Histological |
National Pharmacopoeia |
|
|
Analytical testing |
Moisture, Ash, Acid insoluble ash, Biological and chemical
marker identification, Pesticides, Heavy metals |
National Pharmacopoeia |
|
Issue batch record
|
Verify herb ratios and lots |
Validation |
State Drug Administration |
|
Blend herbs |
Verify proper herb ratios |
Based on biological and chemical markers |
State Drug Administration |
|
Extract herbs |
Verify proper conditions |
Temperature, mixing time, validate that herbs are added.
|
State Drug Administration |
|
Collect liquid extract
|
Verify physical and chemical properties |
Solids, Biological and Chemical markers, pH, Colorimetry
|
State Drug Administration |
|
Concentrate
liquid extract |
Verify physical and chemical properties |
Solids, Biological and Chemical markers, pH, Colorimetry
|
State Drug Administration |
|
Dry liquid
extract into
herb granules |
Analytical testing |
Moisture, Ash, Acid insoluble ash, Biological and chemical
marker ID, Heavy metals, pesticides, micro |
State Drug Administration |
|
|
Government testing |
Moisture, Ash, Acid insoluble ash, Biological and chemical
marker ID, microbiology |
State Drug Administration |
|
Ship granules to U.S.
|
Ministry of Health |
Must meet current export regulations |
State Drug Administration |
|
|
US Customs, USDA, FDA |
Must meet current import regulations |
Code of Federal Register |
|
Receive herbal granules
|
Validate raw material Consistency |
Fourier Transform Infrared Spectroscopy (FTIR) |
Must match the standard |
|
|
Analytical Testing |
Moisture, Ash, Acid insoluble ash, Biological and chemical
marker identification, Pesticides, Heavy metals |
Vitapharmica |
|
Issue batch record
|
Verify herb granules lot number and dosage |
Validation |
State Drug Administration |
|
Compress tablets |
Spot check physical properties |
Disintegration time, weight, thickness, friability
|
US Pharmacopoeia |
|
Coat tablets |
Analytical testing |
Disintegration time, weight, thickness, friability and
micro |
US Pharmacopoeia |
|
Package and label
|
Verify counts per bottle, physical properties of bottle and
microbiology |
Visual inspection and microbiology |
US Pharmacopoeia and Code of Federal Register |
d States for herbs manufactured in
Asia. Every possible step is taken to ensure that all ingredients in these products are 1st pharmaceutical quality.
Thorough testing procedures identify each herb and ensure it to be free of
any adulteration or contamination, including pesticides and heavy metals. In
fact, every batch we receive must be tested and approved by the Ministry of
Health Laboratory before it can be released. The potency of these products is
guaranteed through their entire shelf life 
