Does FSMA Have You Questioning Your Quality Protocols?

Congress passed the Food Safety Modernization Act (FSMA) in 2011 as a response to an increase in reported incidents of foodborne illnesses in the preceding decade. The FSMA requires many manufacturers and transporters in the food and beverage industry (including breweries and wineries) in many cases to comply with current good manufacturing practices (cGMP) and current good documentation practices (cGDP), as has been in place for some time in the pharmaceutical industry. This has been put in place chiefly in order to help the Food and Drug Administration (FDA) better prevent food safety problems, such as foodborne illnesses ( E. coli, Salmonella, C. botulinum, Listeria, Staphylococcus aureus, etc.), instead of only reacting to them. This was done to reduce foodborne illness and death among US consumers.

What Are the Current FSMA Quality Protocols and Compliance Dates?

Most of the deadlines on the timeline for FSMA compliance have already passed for covered organizations not defined as “very small businesses,” who have until late January of 2020 to come into compliance, so if you still haven’t fully assessed your obligations under FSMA, the time to do so is now.

Arguably the single biggest requirement that impacts newly affected businesses is the need to document and implement Hazard Analysis and Risk-Based Preventative Controls (HARPC). The “hazard analysis” part of HARPC revolves around analyzing your facilities, equipment, and processes, identifying potential food safety problem areas, and evaluating the risks associated with those problems. The “risk-based preventative controls” portion focuses on identifying and/or developing preventative controls and implementing them in your facility. You’ll also be expected to monitor these preventative controls to ensure consistent execution and effectiveness, as well as to develop corrective action plans for potential problems that may develop over the course of operations. Finally, you’ll need to document all of the above and produce those documents during any food safety inspections or audits.

How Do I Implement an Effective Sanitation Program That Complies with FSMA?

Implementing a HARPC plan can be a complex and daunting task, but you do not have to be alone in this. Astro Pak has been the leader in providing passivation and high-purity chemical cleaning services for more than 60 years and has unmatched experience in providing beyond cGMP- and cGDP-compliant cleaning, sanitization and passivation solutions for high-purity systems for the pharmaceutical industry and stands ready to continue to provide those services to our valued customers in the food, beverage, brewing and winemaking industries. Our highly trained experts can help you perform the hazard analyses and have the experience to help you develop the controls necessary to achieve FSMA compliance.

Being Proactive About Your Current Chemical Cleaning Procedures

Our research teams are constantly developing new lower cost, greener, and more effective solutions to treat your facilities and equipment with food-safe cleaning chemicals. Once the hazard analyses have been performed, the project management team at Astro Pak can design a cleaning, sanitization and/or passivation solution to meet your needs and our highly trained operational personnel can execute the project plan with skill, speed, safety, and professionalism. After the systems have been treated, we will provide you with cGDP-compliant documentation of the work performed to ensure that inspections are a breeze.

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Seth Matthews

With over 7 years of experience working in Operations and Sales at Astro Pak, Seth Matthews brings practical knowledge coupled with excellent customer service to complex high purity system and equipment cleaning projects. Back by the support of Astro Pak’s R&D team and its 60 years of experience navigating highly regulated industries such as pharmaceutical and biotech, Seth routinely partners with facility managers to engineer FDA compliant cGMP surface treatment processes and chemistries to addresses their unique challenges.

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