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All products included in the stability programs are products with a Drug Identification Number (DIN) or a Natural Product Number (NPN). A batch of each product is tested every 3 to 6 months for 3 or 4 years, depending on the established expiry date of the product. This procedure includes the testing for potency, identity and purity including tests for degradation break down by-products. Physical tests may include disintegration, hardness, pH, etc. The first two lots of a new product are put on a long term stability program. At the end of a testing cycle, a new lot is put in the program. This is the continuous stability mode and is in force as long as the product is marketed.

» Accelerated Stability
As per cGMP – ICH Guidance. The accelerated stability takes place over 3 months on two manufactured lots and all natural health products, as well as all OTC/Rx products (the first two lots), are tested using fully qualified and validated GMP equipment.

» Retained Samples Program
Documents and samples are retained for 1 year after the expiration date of the product as per C.02.021(1) and (2), and C.02.025(1) of the Food and Drug Regulations, respectively. Raw materials, manufacturing, packaging and labels are retained.

» Accepted Quality Limits Program
AQL stands for Accepted Quality Limits. This program includes the stringent inspection of the manufactured goods for uniformity of the tablets or capsules, verification of the surface area for spots, discoloration or other defects, in order to ensure that they conform to established quality levels.

» Vendor Certification Program
Complete certification program of all manufacturers of raw materials and packaging components, API (Active Pharmaceutical Ingredient) certification as per ICH Guidelines Q7A and quality agreements with suppliers for assurance of source of material and conditions of transportation and storage.


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