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Webber

	Botanical Latin Name / Classification
	#103, 3686 Bonneville Place
	Parts Used
	Burnaby
	WN Pharmaceuticals produces a wide range of tested, trusted and effective vitamins, minerals, herbal remedies and other health supplements for the whole family, responding to today's consumer who wants more natural health care options. WN Pharmaceuticals is a "natural" extension of the more than 50 years of service to Canadian consumers provided by "webber naturals", producers of Vitamin E products. Our Farms When you buy herbs you may be getting dried plant parts from anywhere in the world. And certainly not all herbs can be grown in Canada, but at WN Pharmaceuticals we grow our own whenever possible, so we can control the quality, freshness and purity of all herbs we sell. That's as important to us as it is to you. Take our EchinaMaxr products (and we suggest you do!). We grow and harvest fresh, certified organic echinacea purpurea and test each harvest and batch for the herbal components science has determined give echinacea its immune building properties. This combination of traditional, certified organic, farming practices and the latest science in our labs, ensure each EchinaMaxr capsule, tablet or tincture contains all the best of nature's finest echinacea. Our Operations Have you ever been to a supplement manufacturing plant? You might be surprised. Because we are dealing with your health, our products are prepared the same as drugs - with the same intense care and scrutiny. We meet Canadian Government guidelines for Good Manufacturing Practices - the same guidelines demanded of pharmaceutical manufacturers. The difference is only content, not the care taken to bring you products that will enhance your good health. Our Research & Development What products work best? How do they work? Are they safe? It is the job of our WN Pharmaceuticals science team to answer these questions. Armed with degrees in Biology, Medicine, Agriculture, Pharmacology and Chemistry, our scientists help us ensure quality control at every step of production. We have the added benefit of expert herbalists and naturopathic physicians familiar with the unique properties of nature's medicines. R&D WN Pharmaceuticals means reliable, safe and effective products for you. Quality Policy REGULATORY STATUS The manufacturing facility for WN Pharmaceuticals Ltd conforms with the requirements of the Health and Welfare Canada Health Protection Branch under the GMP regulations for pharmaceutical products. REGULATORY BACKGROUND In Canada, WN Pharmaceuticals Ltd deals with two regulating bodies. The Health Protection Branch (HPB), which regulates the production and sale of products with stated health efficacies, and the Canadian Food Inspection Agency (CFIA), which has jurisdiction over products classified as food products. Each of these government bodies has established guidelines and regulations that must be met in order to market product. WN Pharmaceuticals Ltd has an established and respected record of compliance with both sets of regulations. As part of the HPB regulations, production facilities are subjected to periodic inspections to determine compliance to Good Manufacturing Practices (GMP). Adherence to GMP is a legislated requirement for producing drug products. In addition to regulatory bodies, our manufacturing arm maintains an active role with several trade organizations that promote the responsible commerce of dietary supplements, which enhance health and quality of life. Most notable are the Canadian Health Food Association (CHFA) and the American Herbal Products Association (AHPA). QUALITY PROGRAM WN Pharmaceuticals Ltd is dedicated to Quality We are committed to providing the highest quality products to our customers. All of our products undergo rigorous testing at all levels of the production process in accordance with United States Pharmacopoeia (USP) guidelines. Our testing procedures are regulated by the Health Protection Branch (HPB). The lab also follows Good Laboratory Practices (GLP), which requires strict adherence to the following programs: Standard Operating Procedures: A set of written procedures for conducting every operation in the laboratory. Analyst Training Program: Every analyst has the minimum of a university Bachelor of Science degree and undergoes an intense training and safety program. Method Validation: All methods are validated to ensure consistency of analytical parameters including selectivity, linearity, range, accuracy and recovery, precision and ruggedness. Stability Program: Products are tested throughout the shelf life and for one additional year to guarantee that the potency matches the label claim. Instrument Validation and Calibration: To ensure the instrument performs consistently, we validate and calibrate each component of the High Performance Liquid chromatography (HPLC) system as well as the other analytical instruments in the lab. Data Accountability: All of our data are recorded and kept as computer files and hard copies for several years to ensure traceability of all results. Education: Our analysts attend courses and seminars to ensure that we keep up to date with the most current lab technology. In addition, our quality control and quality assurance programs guarantee that our products are among the highest quality available on the market today. What are Quality Control and Quality Assurance? Quality Control is a planned system of activities whose purpose is to provide a quality product through thorough testing. For example, our laboratories test all raw material and finished product potencies in duplicate and verify the (HPLC) High Performance Liquid Chromatography standard preparation using a duplicate standard called a check. We are fortunate to have our own testing facilities available to us and can easily obtain results quickly and efficiently. Quality Assurance is a planned system of activities whose purpose is to provide assurance that the quality control program is effective. We have systems of monitoring and auditing to assure all work is documented and conducted according to our protocol and Standard Operating Procedures. WN Pharmaceuticals Ltd Products are tested at every level of production. Raw Material Testing: Although our raw materials are of the highest quality and are bought from qualified suppliers found all over the world, we still employ rigorous raw material testing to ensure the material is of the highest quality and purity. The raw material must pass all necessary tests before it can be released by the Quality Control department for use in production. When raw material is received from a supplier, it is immediately sampled by the Quality Control department and sent to the lab, which then performs all necessary tests outlined by the USP. Every batch of raw material is tested. There are basic sets of tests, as well as additional tests based on the properties of each compound. The basic tests are as follows: Potency: This test determines the % purity of the raw material. It is performed by HPLC, titration, AA (atomic absorption) and other analytical methods. HPLC uses a Standard of known purity, determined by the USP, and gives a result by comparing the raw material to a standard calibration curve. Titration is a process by which the compound to be measured is reacted with a standardized solution and quantified. Identification: This test is performed by matching the absorption spectrum of a compound to the spectrum of a known pure Standard. Each compound has a unique and characteristic pattern of absorption over a range of light wavelengths. Another way to identify a compound is by a simple chemical test. A chemical test usually involves a colour change or the formation of a precipitate (solid) when particular reagents are added. TLC (Thin Layer Chromatography): This is routinely used as an identification method for herbs. This method is also used to ensure that certain impurities in other raw materials are well below the detection limits. Heavy Metals: This test is performed to demonstrate that the content of metallic impurities does not exceed the trace heavy metals limit. Arsenic: This procedure is designed to determine the presence of trace amounts of arsenic. Loss on Drying: This test determines the amount of moisture in a sample. Loss on Ignition: Some raw materials contain volatile compounds, which are only driven off at extremely high temperatures. This test determines the % of material that is volatilized, or driven off, at approximately 800C. Residue on Ignition: This test determines the percent of material, which is inorganic and non-combustible. Microbial Testing: All of our raw materials are tested to ensure the products are not contaminated with harmful microbials. Once the raw material has passed all necessary tests, it is released by the Quality Control department for the use in products. Testing for pesticides and soil testing are also performed from time to time. Production testing: The Production department has its own quality control requirements. Finished products are tested for weight variation and hardness throughout the production run. These tests ensure that the run is consistent from beginning to end, and that the proper amount of material is in each capsule and tablet. Finished Product testing: Once production is complete, the Quality Control department samples the product and sends it to the lab for more testing. Finished products are tested for: Potency: The same methods are used as in raw material testing, only now; the product may require multiple potency tests for each vitamin and mineral, depending on the formulation. In the case of a multivitamin, up to 12 potency tests may be required. Identification: These tests are performed using the same methods described for the raw materials. Weight Variation: Using a representative sample of the finished product (20 tablets or capsules), the weights are recorded and the average is obtained. The weight variation from the average may not exceed 5% for tablets and 10% for capsules. Disintegration: Disintegration is a physical test. Using a USP certified disintegration apparatus, meant to simulate the movement in a human stomach, we can determine the average time for a representative tablet or capsule to disintegrate. The limits are generally 30 minutes for tablets and 45 minutes for capsules; some tablets are allowed up to 60 minutes, in accordance with the Health Protection Branch. Dissolution: Dissolution tests amount of the vitamin or mineral that has dissolved in a solution over a specified time. Dissolution determines the bioavailability of the product or how much of the material dissolves into the liquid so that the body can absorb it. Using USP certified apparatus, six tablets or capsules are tested in six vessels suspended in a water bath maintained at 37C. Samples are taken at the end of 45 minutes (for single component products) and 60 minutes (for multi-vitamins) and are then analyzed on the HPLC for potency. Time-release tablets are tested at 60 minute intervals to ensure that a steady release profile is sustained over a long period of time. Content Uniformity: This test involves determining the potency of ten individual tablets or capsules to determine the uniformity of dosage units. The Relative Standard Deviation of the potency results may not exceed the USP limit of 6%. Microbial Testing: Although our raw materials are tested for microbials, we conduct additional testing on our finished products to assure that no microbial contamination occurred during the manufacturing process and that the highest quality of product will be available to our customers. View products