Natural Solutions, Clinical Results
In developing Bioclinic Naturals professional health supplements, our first requisite was to offer health care professionals the ultimate in science backed quality, potency and effectiveness. Organic farming, in-house research and development, and strict adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) are all components of the total quality control used to produce Bioclinic Naturals products. Natural Sources
We use raw materials that are sourced from the world’s most trusted suppliers. Audits are done before a supplier is contracted and all raw materials are extensively tested before they are accepted for use in Bioclinic Naturals products. We ensure that each of the following quality steps is adhered to:
- Raw material supplier evaluation - All suppliers are subject to a rigorous vendor and material evaluation process (including on-site inspections and a detailed quality audit) and must meet all of our criteria before we consider purchasing their ingredients. Due diligence ensures the vendor is reputable, reliable and responsible with respect to their environmental and employment practices. Raw material suppliers must meet Good Manufacturing Practice guidelines.
- Raw material evaluation - Whether they come from local suppliers or are sourced from another country, all raw materials go through a rigourous testing program. Samples are obtained, with their certificates of analysis (C of A), certificates of origin, material safety data sheets, allergen reports, storage and stability data, and GMO status, as well as descriptions of processes used in their production, to fully document each material. No material is used until fully tested and until all quality control requirements are met.
- Testing - Quality Control tests, conducted in state-of-the-art laboratories, determine purity, potency and more. Depending on the material, a variety of testing methods are used: high pressure liquid chromatography (HPLC), gas chromatography (GC), inductively coupled plasma mass spectometry (ICPMS), inductively coupled plasma optical emission (ICPOES), electrophoresis, etc. Mass spectrometry is the most advanced analytical technology available for the definitive analysis of natural products. This sophisticated test goes beyond HPLC and GC and can detect contaminants at a molecular level.
- International standards - Every raw material is measured against a pre-written and approved specification document, based on internationally recognized standards. These include USP, BP, EP, etc., however, where no such standard exists, specifications may be based on other recognized standards, such as CRN (Council for Responsible Nutrition), WHO (World Health Organization), etc. per NHPD expectations.
- Regulatory requirements - Regulatory Affairs experts scrutinize each product, ensuring it is safe and efficacious, in compliance with all Canadian regulations, and that any and all label claims are met.
Further testing is done during and after manufacturing to ensure that all finished, packaged goods meet or exceed the most stringent quality standards. Above and Beyond GMP Requirements
The Natural Health Products Directorate of the Canadian government has developed a set of Good Manufacturing Practices (GMPs) that nutraceutical manufacturing companies must follow to obtain and renew their Site Licenses. Bioclinic Naturals facilities meet Good Manufacturing Practices (GMPs) guidelines, as well as the strict regulations of the Australian Therapeutic Goods Administration (TGA).
GMP regulations govern all aspects of the creation of natural health products, divided into four categories:
- Places (premises and equipment)
- People (personnel, quality assurance)
- Processes (operations and sanitation programs)
- Products (specifications, stability, samples, records, recall reporting and sterile products)
Bioclinic Naturals complies with all aspects of these GMP regulations, ensuring that
only the highest quality finished goods reach our customers and
their clients. What this means for a health care professional is that every Bioclinic Naturals product provides known, consistent, health benefits based on researched and measurable levels of known therapeutic nutrients and botanicals. What GMP means to the Health Care Professional
The guidelines for manufacturing mean that Bioclinic Naturals offers quality assurance, analysis and testing; proven procedures, documentation and validation; appropriate and approved equipment and facilities; as well as all required employee training and participation in meeting quality control standards. What this means for a health care professional is that every Bioclinic Naturals product provides known, consistent, health benefits based on researched and measurable levels of known therapeutic nutrients and botanicals. Laboratory "Gold Standards"
Bioclinic Naturals laboratories also meet Good Laboratory Practices (GLP) guidelines that require strict adherence to specific quality standards. These GMP and GLP guidelines, our attention to quality assurance, ensure that Bioclinic Naturals products are pure, potent and contain exactly what is on the label – no more, no less. GLP means that we meet the following commitments: Standard Operating Procedures
A set of written procedures for conducting every operation conducted in the laboratory. Analyst Training Program
Every analyst has the minimum of a Bachelor of Science degree and each undergoes intensive in-lab training. 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 always matches the label claim. Instrument Validation and Calibration
To ensure our laboratory instruments perform 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 data are recorded and kept as computer files and on hard copy for several years to ensure traceability of all testing results. Basic Tests conducted on Bioclinic Naturals Products
Raw material and finished goods testing are fundamental to ensuring the quality and efficacy of Bioclinic Naturals. These are just the BASIC tests used for quality assurance. Other specific tests may be conducted for certain materials, conditions or formulations Raw Materials Testing Potency
This test determines the percentage of purity of a raw material. It is either performed by High Performance Liquid Chromatography (HPLC) or titration. HPLC uses a standard of known purity, provided 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 standard solution and quantified accordingly. Identification
This test can be performed by matching the absorption spectrum of a compound to the spectrum of a known pure standard. Each compound has a unique, 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. Heavy Metals
This testing is conducted to demonstrate that the content of metallic impurities does not exceed any trace heavy metals limit. Arsenic
Any presence of trace amounts of arsenic can be found with this testing. Loss on Drying
This test determines the amount of moisture in a sample. Loss on Ignition
Some raw materials may contain volatile compounds that are only driven off at extremely high temperatures. This test determines the percentage of material that is volatilized and driven off at approximately 800 degrees C. Residue on Ignition
This test determines the percentage of material that is inorganic and non-combustible.
Once the raw material has passed all necessary tests, it is released by the Quality Control department for use in production. Production and Post-Production Testing
The manufacturing department must meet or exceed its own set of quality control requirements. Finished products are tested for weight variation and hardness throughout the production run. These tests ensure that every run, and every batch, is consistent from beginning to end. Finished Product Testing
Once manufacturing is complete, the Quality Control department samples each 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 the product may require multiple potency tests for each vitamin, depending on the formulation. In the case of a multivitamin, up to 12 potency tests may be conducted. Identification
These tests are performed using the same methods as used 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
Using a USP compliant disintegration apparatus, meant to simulate the movement of the human stomach, we determine the time for a representative sample to disintegrate. In general, for tablets and capsules they must disintegrate within 30 minutes in water medium. For more complex formulas disintegration within 45 minutes within a water or simulated gastric medium is acceptable. Extended release tablets/capsules are tested to withstand the simulated gastric medium and disintegrate in simulated intestinal fluid. This is a summary and for exact requirements USP <2040> method should be referred to. Content Uniformity
This test involves determining the potency of 10 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
Micro testing is performed using USP methods. It is intended to protect consumers from deadly pathogens and demonstrate raw materials and finished products are in a sanitary manner. Common testing includes aerobic plate count, yeast and mould, E. Coli, Salmonella, S. Aureus
. Working With Science, Industry and Government
Bioclinic Naturals works closely with industry associations and government agencies to ensure that we provide the latest and best nutritional supplements possible. We are proud to be affiliated with the CHFA (Canadian Health Food Association), AHPA (American Herbal Products Association), ABC (American Botanical Council), CRN (Council for Responsible Nutrition) as well as government regulatory bodies such as Health Canada, the CFIA (Canadian Food Inspection Agency) and Agriculture Canada. Research Based Development and Clinical Testing: CCFM
The Canadian Centre for Functional Medicine, CCFM, is an independent, not for profit, multidisciplinary research facility focusing upon the scientific investigation of natural health products, nutritional interventions and strategies for preventive medicine.
Bioclinic Naturals benefits from the work of the CCFM by implementing and sharing research projects that test, measure and validate key nutritional formulas as well as exploring new and unique supplements and functional foods.
The experts at the CCFM design and carry out formal, human clinical trials to investigate the safety and efficacy of natural health products. They have a close relationship with University of British Columbia in Vancouver and all of their on-site clinical trials are fully reviewed and approved by UBC's Human Research Ethics Board as well as Health Canada's Natural Health Products Directorate.
They also design and assist in the conduct of human clinical trials and animal studies at various off site academic centers, studies approved by the appropriate Research Ethic Boards/Institutional Review Boards and the appropriate government agencies.
The CCFM has also conducted community programs designed to educate the public in matters of nutrition and lifestyle as it related to specific health concerns. For example, community weight loss programs for overweight and obese people in the Lower Mainland of British Columbia. Such programs contribute to the community and help to assess the effectiveness low cost natural ways to prevent such epidemics as obesity and diabetes.
At Bioclinic Naturals, we are committed to providing health-enhancing products backed by scientific and clinical research, and manufactured according to the highest standards of quality in the world.
Read Integrated Healthcare Practitioners
profile on the CCFM