We understand the importance of manufacturing under stringent standards to create consistent, safe and scalable high-quality FMT products. We prioritize quality and safety in every aspect of our operations, and our commitment to producing high-quality FMT products is reflected in our use of both Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) and our Health Canada Drug Establishment Licence (DEL).

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. At Novel Biome, we adhere to strict GMP guidelines to ensure our FMT products meet the highest quality and safety standards.

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.

About Our Manufacturing

At Novel Biome, all our manufacturing and in-house testing is performed in our GMP-certified lab space, following all GMP and GPL practices to ensure the quality, safety, and consistency of our FMT product. GMP stresses the importance of having highly trained personnel, quality facilities and lab equipment, optimization of test systems and processes, and adverse event reporting.

To ensure the Quality, Safety and Consistency of our FMT products we place the highest stands 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
• Adverse Event Reporting