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5 Signs Your Current Good Manufacturing Processes Are Ready for the Food Safety Modernization Act

Submitted by on July 18, 2016 – 11:04 amNo Comment

by Phil Cleary (Christianson & Associates/Biofuels Digest)  The Food Safety Modernization Act covers the operation of a facility that manufactures, processes, packs, or holds animal food for sale in the United States.

Renewable fuels facilities producing feed co-products are no exception. In fact, if you are a biofuels producer that sells co-products later used as an ingredient in animal feed (ex. distillers grains, corn oil, glycerin), FSMA is a multi-faceted regulatory program with which you will soon become quite familiar.

The first phase of FSMA compliance requires implementation of “Current Good Manufacturing Processes” listed in Subpart B of the Code of Federal Regulations (21 CFR 507).

cGMPs help establish the basic environmental and operating conditions necessary to support the forthcoming “Hazard Analysis and Risk-Based Preventive Controls” (HARPC) and Written Food Safety Plan requirements. You might find it helpful to think of these cGMPs as a pre-requisite, phase-1 program that takes place prior to the full FSMA implementation.

While you may have until 2017 (or even 2018) to have FSMA “Current Good Manufacturing Processes” (cGMPs) officially in place based on the FDA’s tiered deadlines, there isn’t any particular reason to delay compliance beyond September 2016.

In fact, ensuring the broadest possible market for your co-products means you should be prepared to handle potential downstream market dynamics that demand ‘day-1’ compliance from suppliers, without regard to their size.

(H)ere are five indicators your facility is on the path to phase-1 FSMA-readiness:

  1. You have assigned key staff to be involved with FSMA implementation, monitoring, and oversight for your facility, and credentialed someone as a “Preventive Controls Qualified Individual” (PCQI). In other words, you know whose job it is going to be to work on this, and have staff assigned to start working on it now.
  2. You understand which of the FSMA compliance deadlines you’re required to adhere, and you’ve made a decision about the timeline you will elect to follow.  …
  3. You’re aware of the broad scope of the FDA’s new rules and subsequent inspection powers and are already anticipating how you’ll adopt and incorporate its brand of formal food safety into your operations as efficiently and effectively as possible.
  4. You’ve identified an industry expert you can partner with to ensure you’re working with the most up-to-date information and make decisions that achieve the required results while balancing the risks of under-compliance and the burdens of over-compliance. A partner can help you keep on track and avoid letting competing priorities and ongoing commitments of time and resources get in the way of timely, proactive implementation.
  5. You have a copy of the FDA’s finalized cGMP requirements, have assessed your current capabilities, and have determined the areas of your operation that will demand the most attention to be brought up to standard. Our FSMA white paper can help with this.   READ MORE

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