Zochem earns FDA designation

BRAMPTON, Ontario—As the pharmaceutical and personal care industries continue to grow and change, companies that serve them must grow and change with them.

The Food and Drug Administration continues to set restrictions and guidelines that firms must follow to stay active in the market.

Zochem Inc., one of the largest producers of zinc oxide in North America, has gained FDA registration, both as a drug establishment and as a food facility, to continue to service these markets.

“It's a segment of the industry that we want to serve,” said Chris Ellen, director of sales and marketing for Zo-chem, headquartered in Bramptom. “They tend to have higher quality requirements, and it's also a higher value product to this segment of the market, being pharmaceutical and personal care.”

As the industry evolves and requirements tighten, “you have to continue to evolve and improve in your own systems, which is what I think our focuses are,” said Khalid Abdullah, IMS Manager at Zochem.

The firm has been selling to this segment of the industry for years, and because it wants to continue to do so, it must continue adapting. “It's an ongoing process where just because we have it doesn't mean we stop evolving, doesn't mean we stop improving on our process to ensure high quality and safety of our product,” Ellen said.

The FDA registration granted Zochem the means to sell its zinc oxide product as a food or drug ingredient. Zochem has been registered with the FDA as a drug establishment since 2003 and as a food facility since 2005.

Ellen said the registration is similar to what the automotive industry has gone through. The automotive industry had to have ISO and then QS9000 certification, among others.

“These things just evolve as industries evolve, and the consumer demands higher quality or we demand higher safety requirements,” he said. “So these things evolve and so Zochem followed along, as well as strive to achieve these registrations.”

Zochem passed an onsite audit by the FDA, which takes three days to complete. The company said its GMP guidelines are integrated into its ISO management system, which is registered to ISO 9001, 14001 and OHSAS 18001. The FDA audit involves scrutinizing and verifying Zochem's GMP process, the company said, and procedures are reviewed and verified.

Abdullah said re-certifications are necessary for both the food facility and drug establishment registrations.

“The drug establishment registration is required to be updated once a year and the food facility one once every other year,” he said.

Meeting the GMP guidelines “gives the customers the assurance that Zochem is able to provide food and drug according to certain minimum standards,” Abdullah said.

Zochem only uses special high grade zinc in all seven of its furnaces, the company reported, and could produce 65,000 metric tons of active pharmaceutical ingredients grade zinc oxide per year.

This type of zinc oxide can go into consumer goods end markets, such as nutra-ceuticals, sunscreen, ointments, insulin, body powder and creams.

Zochem manufactures its products at the Brampton location. Ellen said Zochem believes it is the largest single site producer of API grade zinc oxide.

“We continue to seek opportunities locally and globally. There are many global inquiries about our products because it's recognized as a high purity,” he said.

“Globally, companies recognize that as a value to know that all of our production is done with the purest zinc metal on the market, and we can manufacture the most API grade zinc oxide in the world.”

Because the company is under one roof, its management system is fully integrated, and the firm does not have separate systems for each of those registrations or certifications.

This allows the company to “quickly make changes to increase efficiency and share high quality,” Ellen added. “Because we manufacture everything under one roof, customers don't have to be concerned with which plants the product is coming from. They can audit one facility, and they know that all of their ingredients are going to come from our only facility.”

Zochem reported that all zinc oxide it manufactures never exceeds the heavy metal limits established by the FDA.