The government and government regulatory agencies impose guidelines upon supply chain service providers such as public refrigerated warehouses because they have significant impact on product quality and safety as they are typically the last to handle and/or process the inventory before reaching consumers. Because of this direct connection to consumers, product safety is a critical element.
In many cases, cold storage supply chain service providers must quickly adapt their businesses to meet regulatory guidelines regardless of cost to avoid stiff penalties or shut downs. Some of the most recent regulations impacting temperature controlled facilities include the Food Safety Modernization Act (FSMA), the Sanitary Transport Rule, FDA Title 21 CFR Part 11 and the Drug Quality Security Act (DQSA). Each of these affect operations in a unique way and pose a different set of challenges for each PRW.
The FSMA was signed into law by the Obama administration as part of a movement to increase food safety. In this regulation, the FDA is granted additional power through these provisions: expanded administrative detention, records inspection, authority to deny entry, suspension registration and mandatory recall. This was done in hopes of reducing or eliminating the 48 million foodborne illnesses reported each year.
The sanitary transport rule, as part of the FSMA, is an additional safeguard added to prevent transportation practices that may negatively impact food safety. This new rule applies to shippers, receivers and carriers transporting both human and animal food products within or into the US. Shippers hired by PRWs now must follow strict vehicle maintenance guidelines, operational procedures, data exchange, training protocols and record maintenance.
Another regulation impacting public refrigerated warehouses is FDA Title 21 CFR Part 11. This regulation was initially drafted in 1997 and has been subsequently updated to accommodate new and updated technology. This law regulated what type of electronic signature is acceptable and in what cases electronic signatures are considered valid. This helps to streamline audits, system validations and audit trails required by the FDA.
Lastly, for those PRWs handling pharmaceutical inventory, DQSA designates what inventory and transaction data must be saved and available for FDA if requested. This regulation impacts manufacturers, re-packagers, wholesale distributors, 3PLs and dispensers. Under DQSA, businesses must record transaction information, history and statements.
To learn more about regulations impacting public refrigerated warehouses contact Datex cold storage experts today at www.datexcorp.com , firstname.lastname@example.org or 800.933.2839 ext 243.
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