Certifications & Compliance
TABLET COMPRESSION
We hold all the necessary industry certifications and meet all regulatory compliance requirements for the products we manufacture. Our Standard Operating Procedures are at the heart of our quality system.
LICENSES AND CERTIFICATES
Rhema holds the following licenses and certifications…
- A Health Canada Establishment License (#100228-A) for the manufacture and packaging of OTC drug (DIN) products.
- A Health Canada Site License (#300704) for the manufacture, packaging and labeling of natural health products (NHP).
- Organic Certification (#1621868) and a Gluten-Free Certification (#1041) for various products we manufacture.
- A Precursor A License (#9-0291-2010) for the production, packaging, selling and importing of ephedrine and pseudoephedrine.
We have achieved organic certification status for a select group of products through the SAI Global Organic program. We are also Kosher certified and have been audited as a GIG Gluten-Free facility. If you would like to get these certifications for your products, we will work through the process with you.
The FDA issued an Establishment Inspection Report in July 2011 to RHPL for Food and Dietary Supplements, and no FDA 483 Report was filed.
We also manufacture products tested, marketed and sold under the Informed Choice program. We are a proud member of the Canadian Health Food Association (CHFA) and the British Columbia Food Processors Association (BCFPA).
IN-HOUSE STANDARDS
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 – a set of detailed instructions covering all aspects of operations, ensuring the uniformity of the performance of a specific function.
Each new piece of equipment undergoes a validation study to document that it, 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 on a regular basis 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 License.