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  • Nutralab GMP facilities
  • Certificates & compliance
  • Regulatory services
  • Analytical laboratory testing

Nutralab GMP Facilities

NutraLab follows pharmaceutical grade operation standards, and adheres strictly to Health Canada GMP and US FDA guidelines for natural health product manufacturers. NutraLab’s QC/QA team consists of pharmaceutical scientists and chemists with decades of experience. Our GMP facilities are audited and validated by independent 3rd party.


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NutraLab is a fully licensed contract manufacturing with the following memberships and certificates to ensure we provide the best service and maintain in high standard of the natural products industry to our clients:

We provide certificates of testing

Our in-house lab offers a comprehensive range of analytical testing for routine product release and stability studies using HPLC, GC-MS, AAS with microwave digest systems, and UV Spectrophotometry.

Chemical Analytical Testing include:

• Label Claims Identification Test
• Water content -Karl Fischer Moisture Titration
• AC value and PV values for Fish Oil
• Purity Testing
• Natural Health Product Analysis
• Herbal Analysis
• Vitamin Analysis
• OVI (Organic Volatile Impurities)/Residual Solvents/ Pesticides Analysis with GC-MS
• Metal Elements-AAS with Microwave Digest System for As, Hg, Pb, Cd, Ca, Mg, Zn, Fe, Cu

Physical Testing & Analytical:

• Density
• Hardness
• Friability
• Disintegration
• Melting Point & Melting Range
• Dissolution
• Boiling point
• Specific gravity
• LOD
• pH
• Viscosity
• Particle Size

Stability Studies

Our team can design and manage comprehensive stability studies that follow the ICH guidelines. Conditions offered include:
•25°C ± 2°C / 60% ± 5% relative humidity
•40°C ± 2°C / 75% ± 5% relative humidity

Method Development and Validation

Our analytical services include:
• Method Development
• Method Validation
• Cleaning Validation
• Method Transfer
• Consistency

Microbiology

Our skilled microbiology staff can meet the
needs of routine microbial pharmaceutical
requirements.
• Aerobic Colony Count USP
• E.coli USP
• Salmonella USP
• Staphylococcus Aureus USP
• Yeasts and Molds USP

GMP/Site License

Good Manufacturing Practice (GMP) is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products, and medical devices.

The GMPs are designed to be outcome based, ensuring safe and high quality products, while giving manufacturers, packagers, labellers, importers and distributors of Natural Health Product’s (NHP’s) the flexibility to implement quality systems appropriate for their product lines and businesses.

Natural Products Number (NPN) License

All natural health products require a product license before they can be sold in Canada. Obtaining a license requires submitting detailed information on the product to Health Canada, including medicinal ingredients, source, potency, non-medicinal ingredients and recommended use. Once a product has been assessed and granted market authorization by Health Canada, the product label will bear an eight digit product license number preceded by the distinct letters NPN, or in the case of a homeopathic medicine, by the letters DIN-HM. This number on the label informs consumers that the product has been reviewed and approved by Health Canada for safety and efficacy.

International Trade Certificates (ITCs)

ITCs are documents that contain information about a product or site’s regulatory status in Canada, which serves to assure foreign regulatory authorities that NHPs exported to their countries can be marketed in Canada and meet the NHPR.

ITCs are issued for natural health products that have a valid Natural Product Number (NPN), which indicates that the Natural Health Product Directorate of Health Canada has reviewed the product’s license application and has deemed it safe and effective.

US FDA Food Facility Registration

US FDA registration is required for all companies that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States. NutraLab is fully registered with the US FDA.

Vegetarian (Capsule) Certificate

NutraLab offers vegetable capsules that are suitable for vegans taking dietary supplements.

Halal Certificate

We manufacture natural supplements that are halal certified, which means that our products are permissible under Islamic law.

BSE Certificate

Our BSE certificate certifies that the gelatin capsules we use are free of Bovine Spongiform Encephalopathy (BSE). Our capsules also meet all the requirements of current European Pharmacopoeia (EP) and the United States Pharmacopoeia (SP).

Member of CACDS

As members of The Canadian Association of Chain Drug Stores (CACDS) we represent supply categories and services in the retail pharmacy industry, such as pharmaceuticals, health and wellness products, self-care medications, and other consumer products.

CACDS is there to ensure a strong chain drug store sector which provides Canadian consumers with access to high quality products and health care services.

Member of CHFA

The Canadian Health Food Association (CHFA) is Canada’s largest trade association dedicated to natural health and organic products. The CHFA guarantees their members are operating according to the standards of Canada’s natural health industry.

CHFA members include manufacturers, retailers, wholesalers, distributors, and importers of natural and organic products. These can include foods, vitamin and mineral supplements, herbal products, homeopathics, sports nutrition products, health and beauty aids and more.