Advising operators new to the food and cosmetics business, we often encounter questions that treat FDA registration and GMP compliance as separate, unrelated processes — when in reality the two are inseparably interdependent conditions.
GMP Is the Prerequisite for Registration
As discussed in our earlier article, a food production facility must pass a GMP assessment before it can apply for a food registration number. In other words, GMP is the "before" condition, while product registration is the "after" condition. Operators who try to skip steps by applying for registration before bringing the facility up to standard typically face delays and unnecessary added cost.
An Ongoing Relationship After Registration
Even after obtaining a food registration number, the organization must continuously maintain GMP standards at the facility, since the FDA retains authority to inspect the facility at any time thereafter. If the facility is found not to meet the criteria it was previously assessed against, product registration may be suspended or revoked.
A Recommended Management Approach
We recommend operators treat both processes as one system from the business-planning stage, allocating budget and time for bringing the facility up to GMP standard alongside preparing documentation for product registration. Viewing the whole system from the start helps the business run smoothly and reduces long-term legal risk.