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Quality Assurance and Control for Nuherbs Brand Products

nuherbs® Lab-Tested Bulk Herbs and Teapills

Quality & Safety

Quality and safety is a cornerstone of nuherbs Co.   nuherbs® has been in business for  28 years and their desire for excellence has lead them to the forefront of innovation. nuherbs® chose an Australian TGA GMP facility to produce our Herbal Times® Teapills and Jade Dragon® Classical Formulas, making nuherbs Co. one of the first TCM companies in the United States to adopt GMPs (Good Manufacturing Practices).

At the same time, nuherbs®  utilized several independent laboratories in the United States to ensure nuherbs® teapills meet safety requirement for heavy metals, mircobacteria, and other contaminants. Dual testing by independent laboratories in the United States and the factory’s in-house laboratories in China made nuherbs®  teapills one of the rare lines to ever be dual tested. After constant dual testing for over ten years with no conflicting data, nuherbs® now uses dual testing randomly to assure the accuracy of the factory’s in-house laboratories. 

In addition to the laboratory testing required by the different GMPs, nuherbs Co. conducts additional testing for contaminants such as heavy metals, mircobacteria, and pesticide residues. 

The Labs Used by nuherbs Co.

nuherbs co. is proud to partner with ChromaDex, Inc., the market leader in botanical reference standards, and for the analytical testing of herbs. ChromaDex performs analysis of herbs or dietary supplements for Aristolochic acids using the FDA HPLC method. This FDA HPLC method is currently the method of choice required to accurately test for Aristolochic acids, and is the method being used by regulatory agencies.

The National Food Laboratory, Inc., commonly known as The NFL, celebrates its 30 anniversary in business as an independent and privately owned consulting firm, specializing in Product and Process Development, Consumer Research, Chemistry, Microbiology and Sensory Evaluation for the food industry. With all these integrated services under one roof they help companies get their products to market faster and protect their existing brands.

What are Good Manufacturing Practices?

Good Manufacturing Practices (GMPs) are guidelines that govern the manufacturing process of a product to ensure that the quality and safety of the product is consistent. To ensure compliance and tractability, each step of the manufacturing process must be documented and adhere to its defined guidelines. By documenting the manufacturing process, validating the equipment used, and following preset guidelines, we ensure the quality of each lot of our products.

nuherbs® Herbal Times® Teapills and Jade Dragon® Classical Formulas are crafted at an Australian GMP facility, nuherbs® Herbal Times® Herbal Extracts are produced at British Retail Consortium certified factory, and the newest addition, nuherbs® Lab Tested Herbs, are carefully processed according to traditional methods at a Pharmaceutical Inspection Convention/Scheme (PIC/S) GMP factory.

What is a Material Safety Data Sheet?


A material safety data sheet (MSDS) is a form containing data regarding the properties of a particular substance

Below is a sample of Herbal Data Sheet

HERBAL DATA SHEET

Catalog No:                                       

F11550 (powder)

LotNo:                                                                     

 NHFM05

BOTANICAL DATA

 

Family

Compositae

Botanical Name

Chrysanthemum morifolium Ramat.

Pharmaceutical Name

Flos Chrysanthemi

Common Name

Chrysanthemum Flower

Local Name & Language Translation

Ju Hua   

DESCRIPTION

 

Used Part

Flower-Bud

Property and Taste

Pungent, Sweet, Bitter, Cold

Macroscopic Identification:

 

Powder appearance

Pale yellow / cream-colored powder

Chemical Component:

2,2,4-trimethyl-cyclohexene-(3)-1-carboxylic acid, essential oil

(camphene, camphor, carvone, I-borneol, chrysanthenone),

floavone (luteolin-7-glucoside, cosmoiin, acacetin-7-

rhzmnosyl glucoside0, pigment (chrysanthemin, chrsanthe-

maxanthin), adenine, choline, stachydrine, vitamin B-1

How are Teapills Manufactured?

Teapills Quality Control

Herbal Times® Teapills & Jade Dragon® Classical Formulas

Stage One: Herb Selection

The Purest Herbs Selected from their Indigenous Regions

Quality Control #1

Upon arrival at nuherbs Co. factory, master herbalists inspect the herbs to determine that they are of the correct species and part of the plant. If the herb is one of 500-plus listed in the Chinese Herbal Pharmacopoeia, the chemical analyses listed in the pharmacopoeia will be used to confirm the identification, ensure potency and to test for active constituents. (See below)

The Pharmacopoeia of the People’s Republic of China

A pharmacopoeia is a book containing directions for the identification of samples and the preparation of compound medicines, and is published by the authority of a government or a medical or pharmaceutical society.

The Pharmacopoeia of the People’s Republic Of China is an official and authoritative compendium of drugs. It covers most traditional Chinese medicines, most western medicines and preparations, giving information on the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug.

The current edition of Pharmacopoeia Of The People’s Republic Of China was approved for implementation by the State Food and Drug Administration of China on July 1st, 2005.

The herbs are then washed to remove any dirt or debris.

Quality Control #2

Prior to processing, raw herbs are randomly sampled and inspected to ensure that they meet strict quality control criteria before being blended into formulas.

Stage Two: Herbs are carefully blended into formulas

Quality Control #3

After the formulas are made into pills, each batch is inspected for consistent shape, color, and texture. Pills that fail this test are destroyed. The moisture content and dissolution rate are also tested

Quality Control #4

Officials from the People’s Republic of China’s equivalent of the U.S. FDA regularly inspect nuherbs® factory. Random samples are taken and examined by Chinese Government laboratories for safety.

Stage Three: Bottling & Labeling

Laboratory Testing #1

Each batch of nuherbs® formulas is tested by nuherbs® factory’s laboratory to protect against heavy metal and microbiological contamination. They also test for any known dangers such as Aristolochic Acid.

Laboratory Testing #2

The Import-Export Bureau of China randomly tests Herbal Times and Jade Dragon pills for heavy metals and microbacteria

Import

Laboratory Testing #3

Independent American laboratories examine each batch of Herbal Times and Jade Dragon for pesticides. After testing each batch for heavy metals and microbacteria for the past six years, we have now moved to random testing to ensure that the Chinese laboratories results are accurate. nuherbs® also uses certified independent laboratories to test formulas containing herbs listed on FDA watch list for Aristolochic Acid.

How are Bulk Herbs Tested?

Lab Tested Herbs Quality Control

nuherbs® Lab Tested Herbs

nuherbs® Lab Tested Herbs are an industry first, providing you with the herbs you prescribe most, combined with stringent testing for unparalleled safety for you and your family.

It all starts at the source: Geo-Authentic Herbs

nuherbs® gathers the best herbs from their indigenous regions to ensure that the proper climate, soil and water crucial to the content of active ingredients are present, as most herbs indigenous to one region cannot be properly grown in another. nuherbs® herbs are wild crafted or sourced from 52 GAP (Good Agricultural Practice) Farms when possible. The source of the herbs will be indicated on the COA (certificate of analysis).

Harvesting

In addition to geo-authenticity, we harvest at the proper time of the year to maximize the active ingredients’ potency.

Identification

A Master Herbalist macroscopically examines the herbs to ensure they are the proper species and grade of herb that we desire, and that the herbs are from the highest quality of its species. Extra steps such as TLC tests and microscopic tests are also taken.

Processing

All herbs are furthered processed according to traditional techniques at  PIC/S (Pharmaceutical Inspection Cooperation / Scheme) GMP Certified Plant to ensure the highest effectiveness and decrease the potential of side effects. The GMP quality assurance system protects the whole manufacturing procedure, and documentation ensures that every step of manufacturing is traceable. Products are chosen randomly from each lot for testing.

Herbs are carefully hand-sorted before packing to check for impurities. In addition, nuherbs® have developed thier own protocols and cutting styles, enabling us to specially slice some of the herbs to release their most active ingredient. Moisture is well-controlled to prolong shelf life without the use of any preservatives like sulfuring and nitrogen dioxide.

Testing

Each batch of herbs is dual-lab tested by nuherbs® in-house lab and independent third party lab. nuherbs® in-house lab is equipped with instruments such as a high performance liquid chromatograph, moisture determination meter, Fourier transform infrared spectrometer, atomic absorption spectrophotometer, gas chromatograph, etc.                        
                                                     

In addition, the following additional tests are performed:

  • Microbacteria

  • Pesticides - over 200 pesticides tested for (Uab 2000 screen).

  • Heavy Metals - Lead, Mercury and Arsenic

Packaging and Storage

Processing and storage standards make the difference in preserving the quality of nuherbs® herbs. nuherbs® herbs have a shelf life of 24-36 months. nuherbs® natural herbs retain their freshness and quality without added preservatives. Special measures are taken to store the herbal materials to maintain their optimum required conditions for humidity, temperature and protection from light.

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