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BlueNalu Announces Framework for Food Safety and Quality Assurance for Cell-Cultured Seafood, and Commitment to GFSI Third-Party Certification Early commitment to internationally recognized third-party certification ensures premium quality product beyond domestic regulatory requirements, raising standard across cell-cultured foods globally June 30, 2021 08:07 AM Eastern Daylight Time SAN DIEGO--( BUSINESS WIRE )--BlueNalu, a leading innovative food company developing a variety of seafood products directly from fish cells, announced today its framework designed to achieve a premier standard of food safety, quality, and traceability for its cell-cultured seafood production. The company has committed to pursuing third-party certification recognized by the international Global Food Safety Initiative (GFSI), such as the Safe Quality Food (SQF) or similar programs, as a means to demonstrate the highest possible standards for its safe and trusted cell-cultured seafood products. GFSI certification programs are voluntary and recognized internationally by leading retailers and foodservice operators for setting standards that go beyond domestic government regulations. The programs follow a globally consistent standard for the demonstration of safety and quality and are validated by independent third-party audits. “BlueNalu aims to be a globally leading cell-cultured seafood producer, recognized for the highest caliber of safety, quality, and traceability,” said Lou Cooperhouse, president & CEO of BlueNalu. “Food quality and safety are core values at BlueNalu and it is especially important that we not only meet regulatory requirements, but also establish the highest standards to achieve trusted third-party certification. We are pleased to announce BlueNalu’s commitment to GFSI certification standards for our cell-cultured seafood.” Leading these initiatives at BlueNalu is Noreen Hobayan, MSc, PCQI, its director of quality assurance and regulatory affairs, who has over 25 years of diversified experience in worldwide quality systems, standards, and regulations for the food, pharmaceutical, and medical device industries. Noreen has established a robust click here quality systems framework for BlueNalu and over 100 procedures and policies designed to ensure product safety and supply chain transparency to prepare the company for both FDA regulatory inspection and third-party certification. “It’s imperative that we create a culture of food safety and put comprehensive systems in place to enable traceability of our supply chain. We’re committed to laying the groundwork early for a scalable, top-tier food safety and quality management system that we intend to replicate globally in markets that we enter,” said Hobayan. “By pursuing the highest caliber of safety, quality and traceability in our food production processes, we hope our commitment and leadership raises the industry standard for other companies in our category.” To aid in preparation for market entry and regulatory compliance, BlueNalu evaluated a number of top quality management solutions and selected TraceGains , a global leader in compliance, quality, and innovation software for food, beverage, and supplement companies. Their highly configurable system will streamline and strengthen BlueNalu’s regulatory compliance, allowing for quality control and safety data collection and review in a comprehensive electronic database while providing real-time insight into plant floor and quality operations. The adoption of TraceGains also represents BlueNalu’s shift from pharmaceutical-grade to food-grade sourcing of food-safe components – an important step towards cost reduction that the company anticipates will help it achieve price parity for its cell-cultured seafood products. Elements of BlueNalu’s current quality systems framework include the following: Food Safety Culture: BlueNalu has expanded its Quality Assurance department and is fostering a strong food safety culture through structured trainings and assessments with measurable objectives and progressive goals. Quality Assurance Systems: BlueNalu has developed a robust quality assurance system based on GFSI benchmarking requirements. The programs include strong supplier quality management, validation master planning, prerequisite programs, and a comprehensive food safety plan combined with a seafood Hazard Analysis and Critical Control Point (HACCP) plan. Advanced Quality Control: The company is developing state of the art methods to verify the quality and safety of cell-cultured seafood. Testing will include traditional test methods as well as novel techniques to continuously evaluate the materials, processes and final product to ensure conformance to specifications, bioprocess control, and food safety. Tools and Analytics: Our documentation and traceability policies are designed to ensure materials, equipment and processes meet the highest possible standard.

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“As ISO 27017 and ISO 27018 are extensions to the ISO 27001 standard, we were able to maintain a clear alignment and strategic vision throughout.” This highlights a commitment to privacy and supports compliance with laws and regulations such as the GDPR . “We take an evolutionary approach to system security where we integrate extensions that are relevant to our organization. The OCTO business is based on the processing of personal data – so it was a very natural and logical decision to opt for ISO 27701 certification – especially when considering the need to evidence compliance with the GDPR. For OCTO this represents a moment of great awareness regarding best practice processing of personal data.” OCTO’s integrated management system isn’t solely information security focused. It’s also certified against ISO 9001(quality) and ISO 22301 (business continuity) providing assurance that services are of a high quality which can be maintained even in the most unexpected and difficult circumstances. “Prior to certification, OCTO already had a continuity plan. However, the entire executive committee gave a strong mandate to strengthen that plan to face the most unprecedented situations. This was a crucial decision which meant that OCTO had started the ISO 22301 certifica­tion process long before the COVID-19 pandemic had an impact. As a result, during the pandemic we were able to guarantee the total continuity of our services in every part of the world.” "The high-level structure of Annex SL, with its identical basic text, common terms and definitions, facilitated one-time offer the integration of our management systems" Annex SL, the standardized framework used in all ISO standards, makes it easier for organizations like OCTO to implement a multi-faceted system that can then be audited and certified by a third-party body. Integration helps ensure that multiple systems are pushing towards the same organizational goals, however, it also introduces several other efficiencies. “The high-level structure of Annex SL, with its identical basic text, common terms and definitions, facilitated the integration of our management systems. Through integration, OCTO were able to minimize conflict between individual systems. It also reduced duplication of processes, administration work and general bureaucracy. This ensured a much stronger focus on the needs of the whole business rather than one particular area,” De Bernardo explains. Initially, many of OCTO’s audits were scheduled to take place at a time when the COVID-19 pandemic was causing significant disruption. “All OCTO audits were performed remotely by Lloyd’s Register ,” De Bernardo recalls. “This helped us to find greater efficiencies in the face of minor problems and despite the context of a global pandemic, the process encouraged cohesion and a greater team spirit.
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