The testing of raw materials and finished products is only part of the everyday responsibilities of our Quality Control & Compliance department.
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. Physical samples from the vendor may be required during this review process. Once it is established that the specifications and samples meet the applicable requirements, they are retained as the standard and the materials are ordered. 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. Our QC clerk samples 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. Upon receipt of satisfactory test results confirming conformance to the applicable specifications, the material is released from quarantine and moved to a designated location of the warehouse awaiting its use in manufacturing.
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In-House Testing
In-House testing is performed by QC personnel throughout the manufacturing process to ensure consistent product quality that conforms to the agreed specifications. A strict calibration program is carried out 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 utilize 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 utilize a 2-station VanKel Friabilator.
Label Verification: Labels are verified by QA clerks who proof for two label parameters only: 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, the customer is ultimately responsible for the accuracy of their label. All labels received require a signature of approval from the customer on a Master Label Specification. All labels received are compared against the signed specification. Any changes made to the label will require the customers’ approval on a new Master Label Specification.
Packaging: Testing includes fill accuracy, seal integrity, expiry and lot number accuracy and overall product appearance.
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Third Party Testing
Third party testing is conducted on raw materials, finished products in bulk form or finished packaged products defined by the agreed specifications. Rhema uses 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.
Upon receipt of satisfactory tests confirming conformance to the agreed specifications, the product is released for packaging or shipment in bulk.
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Licences and Certificates
Rhema holds an Establishment Licence (#100228-A), for the manufacture and packaging of OTC drug (DIN) products.
Rhema holds a Site Licence (#300704) for the manufacture, packaging and labeling of natural health products (NHP).
Rhema holds a Precursor A Licence (#9-0291-2010) for the production, packaging, selling and importing of ephedrine and pseudoephedrine.
In addition to their everyday responsibilities, the Quality Control & Compliance Team is responsible for ongoing maintenance and update of our Standard Operating Procedures (SOPs), equipment validation, GMP self-inspections and preparation for Health Canada audits.
The backbone of Rhema’s quality system is its SOPs. SOPs are a set of detailed instructions covering all aspects of Operations that ensure uniformity of the performance of a specific function.
Each new piece of equipment undergoes a validation study to document that the equipment, when operated within established parameters, performs successfully and reproducibly to manufacture a product to an agreed specification.
We evaluate the effectiveness of our processes by conducting GMP self-inspections. The premises, equipment, personnel and application of SOPs are evaluated routinely to ensure compliance with GMPs.
The Health Products and Food Branch Inspectorate conducts a biannual audit of Rhema to validate compliance with Health Canada’s GMPs. Successful evaluation by Health Canada results in our Establishment Licence.