Quality without compromise
From careful scrutiny of raw materials to rigorous in-house testing, our quality control team is constantly working to ensure products of the highest calibre. Third party testing rounds out our quality process.
Before raw materials are purchased, our QC personnel work closely with our Product Development and Sales Teams to ensure that an agreed specification for a raw material or packaging component can be met. We may require physical samples from vendors during this review process.
Once it is established that the specifications and samples meet the applicable requirements, we retain them as the standard and order the materials. Once the material arrives, it is placed in our secure quarantine area and a receiving record is generated in our proprietary ERP (Enterprise Resource Planning) system.
We sample the raw material or packaging component using a GMP compliant sampling method. Raw materials are identified by comparing the sample organoleptically against the standard (i.e. by colour, odour, appearance, texture, etc.).
Packaging components are also measured and compared against the approved standard. Any inconsistencies are brought to the attention of the Assistant QC Manager or Director, Quality and Compliance for further review. Raw materials are then sent out for further testing to third party licensed laboratories. The nature and quantity of tests depend on the agreed specifications. Once we have received satisfactory test results confirming conformance to the applicable specifications, we release the material from quarantine and move it to a designated location of the warehouse to await its use in manufacturing.
In-house testing is performed by our QC personnel throughout the manufacturing process to ensure consistent product quality that conforms to the agreed specifications. We carry out a strict calibration program routinely to ensure QA equipment operational accuracy.
IN-HOUSE TESTING MAY INCLUDE BUT IS NOT LIMITED TO:
- Disintegration: This test is performed to mimic the decomposition of a tablet, capsule or softgel in the gut. Every tablet or capsule manufactured has a specification for disintegration within an acceptable range. We utilize a 4-basket system that meets all current USP requirements.
- Hardness: This test is performed to measure the hardness of a tablet. Every tablet manufactured will have a specification for hardness that falls within an acceptable range. We use a Dr. Schleuniger Tablet Tester.
- Friability: This test measures the breakability of a tablet. Every tablet manufactured will have a specification for friability that falls within an acceptable range. We use a 2-station VanKel Friabilator.
- Label Verification: Labels are verified by our QA clerks who proof for two label parameters: the name of the product (i.e. to confirm that the product is correctly identified) and the quantity per bottle. As a courtesy, we will look for other parameters such as colour, register, clarity and space for lot and expiry printing, however, you are ultimately responsible for the accuracy of your label. All labels received require your signature of approval on a Master Label Specification. All labels received are compared against the signed specification. Any changes made to the label will require your approval on a new Master Label Specification.
- Packaging: Testing includes fill accuracy, seal integrity, expiry and lot number accuracy and overall product appearance.
THIRD PARTY TESTING
Third party testing is conducted on raw materials, finished products in bulk form and finished packaged products defined by the agreed specifications. We use only government approved licensed laboratories. These laboratory tests may include but are not limited to:
Identification: These tests are conducted to properly identify a material using chemical, HPLC, IR or microscopic visual methods.
Purity: These include USP purity tests and tests for pesticides, solvent residues, antibiotic residues, heavy metals and aflatoxins.
Assay: These tests are conducted to measure potency using HPLC, microbial or chemical methods.
Dissolution: This test measures the process by which a solid, gas, or liquid is dispersed homogeneously in a gas, solid, or especially a liquid.
Once we have received satisfactory tests confirming conformance to the agreed specifications, your product is released for packaging or shipment in bulk.