Our Manufacturing Standards
We are focused on manufacturing under stringent standards, and our commitment to this and producing high-quality on-demand FMT products is reflected in our Health Canada Drug Establishment Licence (DEL) and our use of both Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Good Manufacturing Practices (GMP) are a set of guidelines established by regulatory agencies that ensure the quality, safety and efficacy of pharmaceutical and medical products, such as FMT. These guidelines cover all aspects of the manufacturing process, from raw materials screening, standard operating procedures (SOPs) and quality assurance processes to packaging and labelling of finished products.
A Health Canada Drug Establishment Licence (DEL) allows the licensee to legally engage in authorized activities, including fabricating, packing, distributing, testing, etc., of a drug and signifies Good Manufacturing Practices (GMP) compliance. This helps verify that the licensee’s products are safe and high-quality.
At Novel Biome, all our manufacturing and in-house testing is performed following all GMP and GPL practices. GMP stresses the importance of having highly trained personnel, quality facilities and lab equipment, and optimization of test systems and processes.
We place the highest standards on:
Hiring the Very Best Lab Personnel
Purchasing the Best Facility and Laboratory Equipment
Ensuring our Test Systems and Processes are Optimal
Exceptional Manufacturing Processes, Quality Assurance
and Standard Operating Procedures
Stringent Donor Screening, Blood, and Stool Testing
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Our Laboratory and
Manufacturing Space
