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Certifications

Drug Establishment License (DIN)

Empack has a Drug Establishment License (DEL) from Health Canada to manufacture drug products such as sunscreens and other consumer products requiring a DIN registration.

The purpose of the Drug Establishment License is to provide manufacturers a thorough process for risk management while maintaining a standard framework for all Canadian manufacturers. Empack is licensed to fabricate, package and test certain drug products requiring a Drug Identification Number (DIN).

Empack is currently the only Canadian aerosol manufacturer that is licensed to formulate, batch and manufacture DIN products in Canada.

For more information visit the Health Canada website http://www.hc-sc.gc.ca/

Natural Health Products (NPN)

Empack is Site Licensed by Health Canada to produce and manufacture Natural Health Products (NHP) in Canada. 

Natural health products are naturally occurring substances that are used to help restore or maintain good health. They are often developed from plants, but can also be made from other natural substances such as animals and ocean life.  They can be found in a range of forms such as creams, ointments, capsules and drops.

There are many common consumer products classified as a natural health product including hand sanitizers, toothpastes, antiperspirants, and specialty face creams. You can identify products that have been licensed for sale in Canada by looking for the eight-digit Natural Product Number (NPN).

FDA Drug Establishment Registration (NDC)

Empack has a FDA Drug Establishment Registration with the U.S. Food and Drug Administration to manufacture drug products such as hand sanitizers, sunscreens and other consumer products requiring a NDC number.

Drug products are identified by using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. The purpose of the FDA Drug Establishment Registration is to make sure manufacturers are held to the highest standards to protect the public health by making sure all drugs are safe, sanitary and are properly labeled.

For more information visit the U.S. Food and Drug Administration website http://www.fda.gov/

ISO 9001:2008

The International Organization for Standardization (ISO) publishes a set of standards to be practiced by companies. Empack is recognized as ISO 9001:2008 which shows that the company meets the international standard of quality management system requirements. The goal of ISO 9001:2008 is to ensure that suppliers are able to deliver commodities and services that meet the level of expectations and needs of their customers while complying with the applicable regulations which are done by providing a series of requirements.

There are various requirements including: commitment to quality by management, a focus on customers, sufficient resources available, process management, the planning and control of quality, design of product, exceptional customer service, processing of orders, purchasing, resolution of complaints while continually reviewing the quality of products and services both internally and externally (with customers).

Click here for more information on ISO 9001:2008.

Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) provides a series of requirements to control and manage the quality of products that work in accordance with the Food, Drug & Cosmetic Act. Empack is a GMP certified company.

There are numerous requirements for manufacturers to fulfill which include a system of high quality for the design, manufacture, labeling, packaging, storage and servicing of completed products that are prepared to be distributed commercially.

The Empack certifications consist of the development, blending and filling of aerosol and liquid products for the cosmetics industry in agreement with FDA / CFSCAN Cosmetics Good Manufacturing Practice guideline.