Sigan Industries: An Unsurpassed Commitment to Quality

Sigan Industries Inc. is under License with Health Canada. We hold an Establishment License and Site License to Manufacture, Package, Test and Label Drug and Natural Health Products. Sigan is also registered with the USA Food and Drug Administration. These organizations have audited and accepted our approach to Quality Systems.

We strictly adhere to Good Manufacturing Practices for Drugs and Natural Health Products.

To maintain our high quality control standards, Sigan hires only skilled individuals who are exceptional in their field. Sigan’s senior consultants have years of experience working with the FDA and Health Canada. We apply our exhaustive knowledge of regulatory standards to ensure your products meet all expectations.

The Sigan Approach to Quality

Our approach stems from an understanding of the importance of quality controls throughout the manufacturing process. Careful quality controls are set so we consistently deliver a superior quality product.

Our established quality system relies on the consistent application of the following important principles:

• Outlined hiring procedures ensure our staff are qualified within their field and have the personality required to form an effective team.
• We thoroughly train all employees in every aspect of their position.
• We carefully track the receipt and storage of all materials used in our manufacturing processes.
• We document all analyses of our materials.
• We regularly calibrate all equipment and instruments.
• We update our quality control processes regularly to reflect new technologies, new techniques, and new regulations.
• We use a clear protocol so that everyone involved knows and understands what is expected in order to produce superior products.
• We use strict documentation procedures.
• We carefully archive all documents.

This fully-documented quality assurance system has been developed in accordance with GMP requirements and applies to all activities within the company.

The Quality Assurance responsibilities include:

• Product quality
• Handling of Standard Operating Procedures
• Raw Material/Packaging Material testing
• Bulk and finished product testing
• Stability protocol/Process validation protocol
• Preparation and report review
• Monitoring of packaging and labeling processes
• Preparing/processing records compliant with regulatory standards
• Product/Batch release
• The Seal of Approval

Quality is the driving force at Sigan Industries. Our Quality Control department closely monitors every product we manufacture to ensure that quality is never compromised. Every employee at Sigan Industries understands the importance of quality control and is committed to delivering the highest quality personal care products.