Heron Botanicals Quality Assurance Program
Contact Personnel
Vice President: Eric Yarnell, ND, 360-598-5892
Plant manager: Lauren Silver, 360-598-5892
QA/QC manager: Jayme Selig, 360-697-6162
Introduction
Heron Botanicals is currently in the process of creating a complete Quality Assurance Program in line with the federally-mandated good manufacturing processes as part of the Dietary Supplements Health and Education Act of 2004 regulations. Heron will be in compliance with the GMPs by or before the required date of June 2010. It is imperative to realize that Heron Botanicals is a small company and thus we have to be creative in how we comply with the GMPs, which give a wide latitude to help operations of different sizes to comply.
Quality Control Unit
Heron Botanicals does not maintain a separate QC unit. Instead this is an integral function in our production process. The QC manager has the authority to approve and reject all of the following: manufacturing procedures and specifications, test methods and results, raw ingredients and components, finished ingredients, packaging materials, labels, lot and batch records, QC forms, instrument and control calibrations, and reprocessing operations.
It should be noted that unlike many large-scale herbal companies, almost all of Heron Botanicals's raw materials arrive as whole herbs and not powders or extracts. We also obtain almost all our materials from small growers and wildcrafters in North America. These ingredients are much easier to identify down to the species level, often by simple macroscopic examination. Additionally, we have personal relationships with many of these growers and wildcrafters.
Auditing
Heron Botanicals is developing a plant-wide internal audit at this time. No formal audit system currently exists, but informal reviews of our processes have been conducted on at least an annual basis. All audits will be conducted by the vice president. All production staff and the plant manager will be provided with copies of the audit, and all records will be maintained on site as well as on our website. Heron Botanicals will not use independent certifiers or auditors as the cost for such services far exceed the ability of a small company to pay.
The Food and Drug Administration and state or county health or agriculture departments have never inspected Heron Botanicals' facility.
Standard Operating Procedures
All of Heron Botanicals' SOPs will be made available on our website as they are developed. SOPs under development include: personnel cleanliness and training, pest control,
Product Protection
Heron Botanicals will develop a detailed written policy and procedures around protecting against adulteration and contamination. Presently, this consists of visual inspection of all raw materials, and careful selection of growers and wildcrafters who adhere to our same philosophy of working on a small scale in close connection with natural processes. We will be implementing a system of testing every lot for heavy metals and microbial contamination, though we have never had a problem with contamination in the 24 year history of the company. Almost all product is stored in a temperature- and humidity-controlled facility to prevent product degradation. Plant and grounds sanitation is overseen by the plant manager.
Raw Materials
We do not presently audit our raw material suppliers. As stated above, many of these are very small-scale private individual growers and wild crafters with unsophisticated operations. To this end, we will instead continue to focus on monitoring raw materials received, and if a consistent problem comes up with a supplier we will contact them to conduct an investigation. Most raw material certification programs in the industry were developed to handle resellers and large operations that do not directly control the growing conditions of the plants, or that interact with them only as powders. This is simply not the case with most Heron suppliers. We are actively working to reduce our reliance on any large or even medium herbal resellers, though we still obtain almost all raw materials from them in whole form (as opposed to cut and sifted or powdered), making verification and testing on our end much easier.
We are developing a written procedure for receipt, identification, examination, handling, sampling, testing and approval/rejection of raw materials. This includes written specifications for every herb that we process (and since we handle more than 300 species of plants in our total product line, this is a vast undertaking).
We are developing an in-house laboratory for quality assurance of raw materials and finished products. The lab will be overseen by the QA/QC manager. Our current minimum qualification for the QA/QC manager is a bachelor's degree in a relevant field, preferably herbal science, pharmacognosy, plant physiology, biology, or chemistry. Our current QA/QC manager has a bachelor's degree in herbal science. We do not use contract laboratories.
Our plan is to follow the GMPs and confirm the identity of raw materials, test for bacteria, yeast and mold , and to assess for heavy metal contamination. These will be carried out for every lot we receive. Since we do not purchase any extracts made using solvents other than ethanol (and very few of those) there is no need to assess for solvent residue in our operations. We are investigating whether aflatoxin and herbicide/pesticide testing will be affordable. At least initially we may use a contract lab to assess our biggest suppliers for herbicides/pesticides, unless they are certified organic growers. We anticipate the cost for testing for these compounds will be prohibitive and unnecessary since our growers and wild crafters are even more dedicated to avoiding this compounds than we are.
Though we always attempt to obtain certificates of analysis for raw materials, per the GMPs these are not acceptable in lieu of in-house quality assurance.
We do retain samples of all lots received for at least 2 years. We will implement a system to insure that we retain samples of finished goods for at least 2 years past sale of the last amount of it as well.
Finished Products
We are developing written general parameters for finished products. We will do some limited testing of a range of finished products to confirm our suspicion and the published literature suggesting that microbial contamination (other than spores) is not an issue due to use of ethanol in our products. We also add citric acid to our glycerin extracts now to handle concerns about fungal contamination. We will confirm efficacy of this approach with some initial testing when we have our microbiology lab in place. If our suspicions are not confirmed we will make changes to our process to insure non-contamination of finished products. We will not prepare finished product from any contaminated or adulterated raw materials so we will not conduct any other testing on finished products.
We do not make any label claims for potency of our products prior to distribution, so no confirmatory testing is required in this area.
We provide dates of manufacture on labels of all single ingredient extracts, and date poured for all compounded formulas. We have not yet found anyone who has conducted a clinically-valid test of expiration dates in complex herbal extracts. All previous testing has simply been for marker compounds, without demonstrating loss of clinical activity in patients. The cost of such testing is profound. We believe that most of our tinctures and glycerites remain effective for 10 years after manufacture, based on Dr. Heron's and Dr. Yarnell's clinical experiences with our products.
Heron Botanicals has a written policy for handling complaints. The quality assurance manager reviews all such complaints.
Heron Botanicals subcontracts completion of a small number of its products from a company in the United Kingdom known as Phyto, including all creams and a few liquid extracts. All extracts with a product number starting with 4 or 8 are from this subcontractor (and a few that start with a 7), as well as all creams. We have not audited this subcontractor. We have systematically eliminated most products we purchase from them by preparing them from raw materials sourced in the US. We use them only for products we have been able to source anywhere else at the same level of quality. Given the small volume of materials purchased from them we are not going to institute an expensive auditing system for this supplier.
No major food allergens (milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, or soybeans) are produced, handled, or stored at or near this facility.
Heron Botanicals has never had a complaint of any product being adulterated or contaminated and has never had to initiate a product recall in the entire history of the company.
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copyright 2006 by Heron Botanicals
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