100% Canadian owned and operated 100% Canadian owned and operated

Quality Assurance

SOUL Pharmaceutical Ltd > Quality Assurance

At SOUL Pharma’s Affiliated Companies, Our Onsite Laboratory Gives Us Control Over The Quality And Integrity Of Our Products.

We Perform 90% Of Testing Requirements And Environmental Monitoring In – House – Giving Us Continual Control Over The Integrity Of The Production Process.

6

Our Comprehensive Testing Regime Includes:

2

Microbiological Tests

The SOUL Pharma’s Affiliated Companies In-House Microbiological Laboratory Performs Testing For Microbial Contamination To Ensure That The Raw Materials And Finished Products Will Meet Specifications For Microbial Contamination. Recognized Pharmacopeias, Such As The USP, Are Used For:

  • Total Aerobic Counts
  • Total Combined Molds And Yeast Count
  • E. coli
  • Salmonella spp.
  • Staphylococcus aureus
  • Pseudomonas aeruginosa
  • Listeria And Bile-Tolerant Gram-Negative Bacteria Assays Are Conducted For Probiotics Products

In Addition To Above Tests, Pharmaceutical Products Are Also Required For Testing For The Following Microorganisms:

  • Clostridia
  • Candida albicans

The CFIA inspects, samples and tests food products that have a potential for health risks. Samples are analyzed based on the food safety standards that have been established by Health Canada and various international organizations, such as the Codex Alimentarius Commission. Sample tests are done every year to monitor the level of microbiological contamination in the food supply. Testing For Biological Contaminates On Raw Materials And Finished Product.

3

Physical Testing

A Full Range Of Methodologies To Assure Appearance, Taste And Physical Characteristics

5

Chemical Testing

High Pressure Liquid Chromatography (HPLC), Atomic Absorption Spectroscopy (AA) And Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) For Raw Materials And Finished Product To Assure The Purity Of Vitamins And Trace Minerals

8

Heavy Metals Testing

(ICP-MS) To Test For Heavy Metal Contamination

Regulatory Compliance

Consumer Confidence In Nutritional Products Comes From Manufacturing Expertise, Quality Assurance And Regulatory Compliance.

SOUL Pharma and the Affiliated Companies Believes That The Future Growth Of The Industry Rests On Maintaining Consumer Confidence In The Products That We Produce.

The SOUL Pharma’s Affiliated Companies Regulatory Affairs, Document Control And Compliance Department Provides A Complete Set Of Services To Assist Its Clients, Including:

  • Regulatory Review And Evaluation Of Consumer Labels And Labeling.
  • Review Of Promotional, Advertising Printed Materials, Product Disclosures And Other Documentation To Ensure Regulatory Compliance.
  • Creation Of Product Regulatory Dossiers For Product Marketing And Global Product Registrations And Renewals.
  • Maintenance Of Site Licenses And Registrations, Including Issuance Of Foreign Site Reference Number Authorization.
  • Assistance In Completing Web-Based Product Registration In Compliance To Retailer Industry Standard.
  • Completion Of Audit Questionnaires, Third Party Global Compliance Assessment And Global Platform.

Maintenance Of Raw Material Reference Database To Respond To Customer Inquiries On Product Ingredients’ Regulatory Status And Compliance.

Licenses Info

SOUL Pharma and the Affiliated Companies Maintains Full Compliance With All Applicable Regulatory Licensing Regimes, And Supports The Industry’s Voluntary Programs To Assure The Highest Quality Of Production Standards.

Health Canada – Pharmaceutical Drugs
SOUL Pharma’s Affiliated Companies Holds A Valid Establishment Licence For The Purposes Of Fabricating, Packaging / Labeling, Testing, And Distributing.

Health Canada – Natural Health Products
SOUL Pharma’s Affiliated Companies Holds A Valid Site Licence For The Purposes Of Manufacturing, Packaging, Labeling, And Importing.

Halal
SOUL Pharma And the Affiliated Companies Is Certified As A Halal Facility And Conforms To Halal Standards For Production Of Specific Products. A Complete List Of Halal Certified Products Can Be Obtained Only Through SOUL Pharma And the Affiliated Companies.

US Food And Drug Administration
An Official Letter Was Received From The US Government Indicating That SOUL Pharma’s Affiliated Companies Facility Was Being Classified As Acceptable.

FSMA (Food Safety Modernization Act) Compliant
SOUL Pharma’s Affiliated Companies Is An FDA – Registered Companies, AND Is Current And Compliant With The Requirements Of The Newly Enacted Food Safety Modernization Act (FSMA). – Which Establishes Federal Governmental Standards For Safe Production Of All Food And Food Supplemental Products Manufactured In The Canada.

FSVP (Foreign Supplier Verification Program) Compliant
Raw Materials Used In Nutritional Supplement Manufacturing Come From Many Sources Worldwide. Recently Enacted To Protect The Consuming Public, The FSVP Requires Manufacturers To Certify That The Quality All Ingredients From Foreign Sources Adhere To The Same Standards As Those Produced Domestically.

Food GMPs Title Compliant
A Formalized Program For Food Safety That Includes Sanitation Standards Incorporated In Standard Operating Procedures (SOPs) Along With Hazard Analysis And Critical Control Point (HACCP).

Dietary Supplements
SOUL Pharma’s Affiliated Companies Holds An Organic Processed Product Certificate For Dietary Supplements, And Is Certified To Operate By CFIA.