Part 1- Coping with the proposed CGMP and HARPC Regulation: Strategic Planning
A recent decision by the US District Court for Northern District of California has reset the time frame for rule-making of many of the FSMA key sections, including the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Foods. The deadline for comments is now November 15, 2013, and FDA is required to publish the final regulation no later than June 30, 2015. The same deadlines apply to the Produce Safety Rule. Other rules, such as Food Defense regulations, Preventive Controls for Animal Food, and Sanitary Transport regulations, are also due out as final rules on 6/30/15. With all these new regulations coming at the food industry, what is the best strategy to wrap our arms around this onslaught and get a plan in place for compliance? How can we minimize regulatory risk to our company, comply with requirements, but still control associated costs?
In this blog we will explore strategic and tactical approaches to managing FSMA regulatory compliance, looking at both the currently enacted regulations, such as the Whistleblower Provision and Biennial Registration, and the proposed regulations, such as Preventive Controls for Human Food. The strategic approach is the “big picture view”, usually set in the executive suite, and establishes direction for the company on how compliance will be addressed and what are the mission and objectives (“what will be done”). To make compliance happen, we need a tactical approach to get the ball rolling in the plant (“how it will be done”). This involves important changes to plant operations and food safety management. A key tool to move us down the road of implementation is gap assessment, which will help us build a road map for implementation. We will start with the HARPC rule first, and then apply the same type of approach for coping with Whistle Blower Protection, Records Access, Registration, and other proposed FSMA rules.