Although the quality control procedures we have in place are stringent and extensive, they are only part of the story. Equally important is working closely with industry associations, such as the CHFA (Canadian Health Food Association), AHPA (American Herbal Products Association), ABC (American Botanical Council), CRN (Council for Responsible Nutrition) to name only a few, and government regulatory bodies such as Health Canada, the CFIA (Canadian Food Inspection Agency) and Agriculture Canada.

We stay up to date on the latest regulations, research and other issues affecting our industry. We are committed to a significant investment in research and development, and have strong ties within the global research community. All of our labs follow GLP (Good Laboratory Practices) guidelines; all our manufacturing and production facilities are GMP (Good Manufacturing Practices) approved, and as a company we were one of the first nutraceutical companies in Canada to be issued a Site License by the NHPD. A Site License is required for any business in Canada wanting to manufacture, package or sell a natural health product.
 
EXPLAINING GMP
 
The NHPD has developed a set of Good Manufacturing Practices (GMP) that each company must prove they are following in order to obtain and renew their Site License. GMP regulations govern all aspects of natural health products, and are divided into four categories: Places (premised and equipment), People (personnel, quality assurance), processes (operations and sanitation programs), and Products (specifications, stability, samples, records, recall reporting and sterile products). All aspects of the places, people, processes and products falling under the natural health product category must legally comply with GMP regulations, ensuring that only the highest quality finished goods reach the Canadian public.
 
GMP adherence can be summarized under four headings:

•   Quality assurance, analysis and testing
•   Procedures, documentation and validation
•   Equipment and facilities
•   Employee training and participation

EXPLAINING GLP
 
Factors Laboratories also meets Good Laboratory Practices (GLP) guidelines which require strict adherence to the following commitments:
 
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 data are recorded and kept as computer files and on hard copy for several years to ensure traceability of all results.  
 
The basic tests are as follows:
 
Potency:
This test determines the % of purity of the raw material. It is either performed by HPLC or by 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.

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 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 may contain volatile compounds that are only driven off at extremely high temperatures. This test determines the % of material that is volatilized and driven off at approximately 800 degrees C.

Residue on Ignition:
This test determines the percent 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.

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.

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, 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:
Using a USP certified disintegration apparatus, meant to simulate the movement in a human stomach, we determine the average time for a representative sample to disintegrate. The limits are generally 30 minutes for tablets and 45 minutes for capsules. Some tablets are allowed up to 1 hour in accordance with the Health Protection Branch.

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.