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Quality Control of Botanical Ingredients
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Quality Control of Botanical Ingredients

Article Source:Xi'an Yunuo Bio-Engineering Co.,LtdPublished Time:2016-11-6 16:09:23
Quality Control of Botanical Ingredients

     Partnerships with dependable, quality-conscious suppliers are key to a manufacturer’s reputation and success.

     As the nutrition science industry grows, so do the questions and  concerns regarding quality. Most, if not all, quality-related questions  can be answered by evaluating the cultivation and harvesting practices,  the manufacturing practices and the quality control program adopted by  the ingredient suppliers.

     Manufacturing Practices

     Manufacturing processes affect the quality of herbal ingredients.  Cross-contamination with other products, environmental contamination,  mix-ups and mislabeling can lead to poor-quality material. These can be  avoided by implementing Good Manufacturing Practices . It is therefore  important to check and evaluate the manufacturing practices of suppliers  to ensure high-quality botanical products.

     Ingredient Specifications

     A quality botanical ingredient is one that uses the correct plant  species and plant part, is unadulterated, safe for human consumption and  has the potency (level of chemical constituents) it claims.

     Different types of identification methods, such as macroscopic,  microscopic, organoleptic, thin-layer chromatography (TLC),  high-pressure (HP) TLC, HP liquid chromatography (HPLC) and Fourier  transform infrared spectroscopy, may be used to identify the genus,  species and plant part. Each of these identity tests has advantages and  limitations. In most cases, different methods must be combined to  identify the plant species and plant part beyond a reasonable doubt.

     Aflatoxin and microbiological testing are required to ensure the  product is free of pathogenic bacteria and is safe for human  consumption. Raw ingredients usually have a high microbial load and thus  require some form of sanitization. Several sanitization options are  available, but it is important to understand the regulatory and quality  impact of such sanitization processes before choosing one that is  appropriate for the specific product.

     One of the very first things needed to ensure the quality of botanicals  is to create an ingredient specification sheet detailing identity  (genus, species, plant part), physical (appearance, particle size,  density), chemical (chemical constituents, marker compounds), heavy  metal, pesticide and microbiological requirements as well as the  preferred sterilization process. Since using different methods could  lead to different test results, it is important to identify the  sterilization and test method on the specification sheet.

     In the case of botanical extracts, the ingredient specification should  also list the raw herb-to-extract ratio, extraction solvents used and  any excipients and/or carriers that may have been used in the production  of the herbal extracts.

     Certificate of Analysis (COA)

     The ingredient supplier should provide a COA with all shipments. The  results of identity, physical, chemical, heavy metal and pesticide  residues testing as well as microbiological testing results should be  listed on the COA along with the specifications and methods of analysis.  The COA should be a guarantee that the product is what it claims to be,  is unadulterated and is safe for human consumption. However, the COA  provided by the ingredient supplier should be verified and the test  methods used should be evaluated. It is important for suppliers and  customers to agree on test methodologies prior to accepting COA results.

      Ingredient Supplier Selection

      A key step in ensuring the quality of finished products is choosing an  ingredient supplier that will provide material that meets all of the  requirements. The vendor should be provided with the detailed ingredient  specification—which should be part of the contract with the customer—so  that they can fully understand the customer’s requirements. The  supplier should review the specification thoroughly and provide feedback  to the customer in the form of comments or ask for further  clarification. The customer and supplier should agree on the ingredient  specification before placing or accepting orders.

     It is very important to review and evaluate the vendor’s capabilities  and expertise. Some areas that need to be evaluated are the vendor’s  quality unit, including but not limited to the education, training and  experience of the quality unit staff. The vendor’s Standard Operating  Procedure programs, testing capabilities (including certification of any  third-party testing labs used), laboratory equipment, sanitation  programs, process control and pest control programs are some of the  areas that should be evaluated. A site visit and audit of the vendor  facility provide critical information regarding vendor quality.

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