Good manufacturing practices (GMP) have been adopted by many countries to protect consumers from unsafe products. Regulatory agencies such as the US Food and Drug Administration (FDA) used to focus primarily on domestic GMP compliance and enforcement. With an increase in the number of importers sourcing products from abroad, there has also been an increase in the number of FDA inspections. Getting ready for an FDA inspection will not only help you prepare for an audit but also help you protect your customers from potentially unsafe products. With the Food Safety Modernization Act (FSMA) coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect food facilities, and they won’t always show up announced.
Know About FSMA
The Food Safety Modernization Act (FSMA) came into existence in January 2011 with additional rules from September 2016. FSMA enables FDA to scientifically evaluate food safety and preventive control measures implemented in a food manufacturing facility. The law focuses on preventing contamination during food manufacture that may hamper food safety along with providing documentary evidence on the process of generating safer products. The act addresses all segments of food production that the FDA regulates.
Are You Ready for an FDA Inspection?
It is very important to pinpoint several details to be adequately prepared before an FDA audit. The repercussions of a failed audit can be detrimental to the future of your organization and may lead to food recalls. The following is an important pre-inspection checklist for food manufacturers prepping for an official inspection:
1. Decide on a Place to Host the FDA Investigators
A typical FDA inspection usually takes one to three days, depending on the scope of the inspection and on-site findings. Upon their arrival, escort them to a designated conference room where the FDA inspection team will hold a meeting with the organization’s management representatives to inform them about the purpose and scope of the inspection. The conference room must have enough space for the investigators to easily review records.
2. Finalize Your Auditee Team
An important step in the preparation process is to identify the auditee team and its roles. Team members can include key users, staff from technical support and user support, IT personnel, lab managers, and analysts. The team members should be able to present an overview of the manufacturing and quality control processes, recording minutes of the meeting, screening necessary documents, etc. Once the team members are finalized, they should be provided with audit interface training. The staff members designated to coordinate with the FDA investigators should undergo Preventive Control Qualified Individual Training; although it is not mandatory.
3. Make All Necessary Documents and Records Easily Accessible
As investigators usually review the records of the preceding three months, you should be prepared to provide the same in a well-organized manner. Few important documents you should keep handy include documents related to process validation, production and process control, equipment maintenance, back-up & recovery, complaint records, quality manual, analytical instrument list, corrective and preventive actions (CAPA) taken, shipping records, and staff training documentation. You must also keep a food safety plan ready that includes GMPs, recall plans, environmental monitoring program, sanitary transportation plan, and foreign supplier verification plan.
4. Document Corrective and Preventive Actions (CAPAs)
You can expect investigators to examine CAPAs as well as your recall processes. Ensure that your team is clearly and completely able to explain and show records related to customer complaints, the necessary processes to handle them, and the actions taken to prevent their recurrence.
5. Ensure the Products are Properly Labeled
FDA investigators are most likely to test the knowledge of your staff about the products. Ensure that you are completely prepared with answers on the raw materials used, their source etc. and can retrieve the required product readily if asked. Labeling them properly will help you organize the materials so that you meet FDA expectations. Labeling is important for food traceability. The labels must state the raw materials that make up a product and the country from which the ingredients are sourced. The information on raw materials and their sources is important since each country has its own authorized testing methods and has different foodborne pathogens and potential contaminants.
6. Conduct Environmental Monitoring and Sampling
FDA will expect you to have an environmental monitoring program in case your company processes ready-to-eat food products that are exposed to the environment before packaging. An environmental monitoring program comprises testing protocols for foodborne pathogens. The program also helps determine if the preventive measures undertaken are appropriate for containing any contamination. To determine the effectiveness of the preventive measures, food manufacturers must determine the sampling locations, the number of sites from where the samples need to be collected, timing and frequency of sampling and sample testing. Analytical tests must then be performed to detect contamination by pathogens. All tests conducted along with the test results must be recorded with a date and time stamp. During audits, FDA investigators might also collect samples from your facility. Hence, you need to be sure about how exactly you can help them find the same. Additionally, the results obtained from the environmental monitoring program must be easily accessible so that you can quickly produce them before the auditors.
7. Get a Food Industry Lawyer
Your emergency contact list must have a knowledgeable and experienced food industry lawyer to help answer any regulatory or investigator-related questions that may arise during the process. The lawyer should be notified in advance and should be available during the inspection.
8. Run a Mock FDA Inspection
This could be the last but an important step of your preparedness program. Conducting a mock audit is one of the best ways to shore up your ability to engage investigators when the time comes and to readily answer the questions asked by the auditors with confidence. You can ask someone who has been through many audits to perform as a mock FDA inspector and test the preparedness of your auditee team. This will help you learn your shortfalls and implement improvement strategies, strengthening your chances of passing an official FDA audit.
The inspection usually ends with a closing conference to discuss observations and violations found on the site, if any. This provides the organization’s representatives with an opportunity to discuss any inaccuracies before the results are finalized.
Role of a Food LIMS to Meet FSMA Requirements
A Laboratory Information Management System (LIMS) plays an important role in meeting several requirements of FSMA. A Food LIMS can help in the following ways:
- Manages, communicates, and allows quick access to quality data
- Manages sampling data and test results, including quality control results
- Maintains a chain-of-custody to track samples from accessioning to disposal
- Integrates with analytical instruments to automatically record analytical data, maintaining data integrity
- Helps generate custom test reports or Certificates of Analysis (CoAs) once the test results are validated and approved
- Provides a complete and secure solution to manage, track, and monitor all batches of products
- Helps manage final product specifications and pricing
- Generates 1D and 2D barcodes for tracking samples back to the original and finished product
- Helps authenticate key laboratory activities through electronic signatures
- Tracks and manages CAPAs and associates them with test results for easy management which increases customer satisfaction
- Eliminates manual work and typological errors
- Makes data more useful with easy retrieval or visibility
- Acquires and manages environmental monitoring data
- Manages shelf life studies
- Manages training and competency records of staff
- Manages documents, such as Standard Operating Procedures (SOPs), and provides quick access of documents to all authorized users
- Maintains an audit trail of all activities with a date and time stamp and helps generate audit reports to report any changes made to the test results
- Manages instruments along with their calibration and maintenance data
- Manages workflows to ensure laboratory staff follows pre-defined work order
Many firms are unprepared to manage an FDA inspection as it is usually not announced. However, do not wait until an FDA inspection to find and address potential issues at your manufacturing facility. With an increasing number of international facilities adopting to manufacture goods as per FDA regulations, preparing for an inspection is vital. Preparing for an FDA inspection often requires a lot of time and effort. Hence, the above-discussed steps will help you to be ready for an official inspection.
A LIMS has been a reason for the success of many food companies. It organizes and securely manages all stages of food testing, helps meet regulatory guidelines, strengthens communication within an organization, and increases productivity. A LIMS allows food companies to meet their goals and comply with the FSMA requirements by protecting their brand and by providing high quality, consistent, and safe products to consumers while operating efficiently.