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Reportable Food Registry – Food and Beverage Processors Must Now Report Issues within 24 Hours via the FDA’s RFR Electronic Portal

Monday, September 21st, 2009 by admin

As of September 9, 2009, food and beverage processors are mandated to report all reportable food incidents to the FDA’s Reportable Food Registry when, “there is reasonable probability that an article of food will cause serious adverse health consequences.”  This mandate applies to all food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.  Details of this program are available via the FDA’s Reportable Food Registry resource Web page.

The program includes reporting key data during an initial disclosure and via follow-up reports including items such as the date the article of food was determined to be reportable, a description of the food including quantity and amount, the extent or nature of the adulteration, the result of investigation to determine the cause of the adulteration, disposition of the article of food, and product information typically found on packaging sufficient to identify the article of food.

Once the submission is completed, a confirmation page identified via an Individual Case Survey Report ID (ICSR), including all submitted information, is produced.  This report can be saved as a PDF file and associated with key data elements in the food and beverage processor’s Enterprise 21 ERP system, including customer incident reporting, lot traceability data, and associated customer shipments.

Food and beverage processors are strongly encouraged to review their Comprehensive Recall Management plans and make appropriate adjustments based on the FDA’s Reportable Food Registry mandate.  For an overview of the Reportable Food Registry, please review the FDA’s “Reportable Food Registry (RFR): At a Glance” document.


Creating Certificates Of Analysis And Pedigree Documents For Process Manufacturing

Friday, June 26th, 2009 by admin

Safety and control – these are two words that are commonly heard when discussing key elements in today’s life sciences and food and beverage industries. Public and private sector entities alike are taking more action to make sure companies who do business in these industries are adhering to strong safety and control practices.

One of the ways in which businesses work to protect themselves and those with whom they do business is by receiving and making readily available certificates of analysis (commonly referred to as COA’s) from suppliers along with the ingredients they buy for use in manufacturing operations. COA’s are documents which provide a quantitative analysis across a series of properties for the associated item. For example, a COA for soya lecithin powder or ginger extract would generally include microbiology results for properties such as total plate count, E.coli, and salmonella levels, as well as a variety of other properties.

Life sciences and food and beverage companies will typically receive ingredients and automatically place them on quality hold upon receipt. Then, these businesses will alert quality control (QC) specialists that there are items that need to be inspected prior to their release for use.

The QC department will run a series of tests on samples of the given product received and verify that the properties on the COA match up with the properties of the product being tested. Assuming these tests pass muster, the product is then released for further consumption in a manufacturing process. Should the product not pass the QC tests, laboratory personnel will then run further tests while involving the supplier’s QC personnel to help evaluate potential issues with the ingredients before determining what to do next.

These same types of QC tests are performed on finished goods which are manufactured by life sciences and food and beverage companies prior to their release for shipment to their customer base. Again, a COA is created to accompany the specific lot of produced product to the manufacturing company’s customers.

Another document which is becoming more prevalent in the life sciences industry is a pedigree document. A pedigree document traces the complete chain of custody of the given end item from original manufacturer through various distributors until it finally reaches a retailer for sale. State governments such as Florida have a predefined prescription drug pedigree document which must be passed along the supply chain with each associated company adding its information and signing off on the document throughout the channel.

Strong business management systems like TGI’s Enterprise 21 ERP system can be used by life sciences and food and beverage companies to automate and maintain strong product safety and control procedures including the creation of certificates of analysis and drug pedigree documents.


Establishing and Maintaining a Comprehensive Recall Management System

Friday, June 5th, 2009 by admin

What do pistachios, cough and cold medicine, cheese, dietary supplements, cookies, fruit and nut blend, and alfalfa sprouts all have in common?  They all appeared on the US FDA’s recalls, market withdrawals, and safety alerts list during April 2009.

Many companies that believed they were immune to this process have recently had to initiate recalls.  Some of these companies were so ill-prepared they had to close their doors due to poor preparation for such a possibility.

So, what do companies in life sciences and food and beverage industries need to do to make certain they are well prepared for a potential recall initiation?  Companies need to have automated lot tracking software functionality and a comprehensive recall management system in place.  At the core of a comprehensive recall management system are well-defined policies and procedures to be followed in the event of a recall.

The Ohio State University Extension published an excellent article on this subject titled, “What Can You Do to Be Ready for a Recall?” which overviews what companies can do to avoid the potential need for a recall and a high-level summary of the procedures that should be followed in the event that it becomes necessary to initiate a recall respectively.

Key points made about how to avoid a recall include having a Hazard Analysis and Critical Control Point (HACCP) plan in place, complying with the FDA’s current Good Manufacturing Practices (cGMP) regulations, developing and maintaining quality management systems, developing a food security and tampering prevention program consistent with the FDA’s Bioterrorism/Food Safety Security Act of 2003, and ensuring quality of raw materials by working with credible suppliers.  When defining a recall plan, one must pay special attention to the key element of such a plan which is fact gathering about the defective product.  This includes both internal and external discovery.

In TGI’s Enterprise 21 ERP system, service and support functionality can be used as a coordination point for external discovery.  This includes logging of all support calls, routing to appropriate resources for investigation, and documenting and tracking the associated resolution.  A recall coordinator would be alerted should the problem be determined to be of sufficient nature and require immediate action.

Enterprise 21 manages internal discovery by supporting complete chain of custody tracking through lot traceability of inbound ingredients, their consumption in manufacturing processes which can yield intermediates, and ultimately to finished goods which are shipped to customers.  In addition, quality data is recorded for each lot during this process.  Enterprise 21 supports both forward and backward lot traceability.

Through a combination of policies and procedures, along with strong system functionality for quality management and lot traceability, TGI customers leverage the Enterprise 21 ERP system as a key element of their comprehensive recall management systems.


Establishing the Complete Chain of Custody of Your Products through Lot Tracking

Thursday, March 19th, 2009 by admin

One of the hottest topics in process manufacturing is lot traceability. The definition of lot traceability is the process of tracking given material lots throughout the enterprise and beyond. Lot traceability includes tracking lots forward from ingredients through manufacturing processes into finished goods, which are ultimately shipped to end customers. This also includes tracking lots backwards from finished goods back into the manufacturing processes and then back to the ingredients consumed in the production processes.

In ERP systems with strong process manufacturing support like Enterprise 21, companies who have a need to track lots should be able to do so easily and in an automated manner. This is a key element for establishing good system and procedural controls within one’s business, and should the need arise for a product recall, make the isolation process easy and straightforward while minimizing the amount of product necessary for inclusion in the recall.

Most companies without a modern ERP system that includes sophisticated lot tracking software functionality are managing their lot data in a suboptimal manner. Many of these companies may simply be recording lots on hard copy logs, using a series of spreadsheets to key in this data, or a combination of these methods. Not only does this process create a large amount of manual efforts, it leaves operations vulnerable to a significant amount of data entry errors and potential compliance issues.

What a good ERP software package like Enterprise 21 offers is two-fold. First, one can establish and record lot properties, which is a series of corresponding values for a given product’s physical characteristics. This practice is a key element in the quality control (QC) process. Second, one can record the complete chain of custody or pedigree of lots through the enterprise and beyond. Both of these steps are critical requirements for strong lot traceability and compliance.

Relative to system-enabled lot analysis for ingredients, when ingredients are received, the associated lots are recorded. Those received lots would typically be placed on QC hold and the inspectors alerted as to the need to inspect and analyze these lots. The inspectors would perform their analysis and record the values for the associated ingredient lot properties. Assuming the values observed and recorded were within the acceptable range for the various lot property characteristics, then the given lot of ingredients would be released to available inventory for consumption in manufacturing processes.

A similar process can be performed for system-enabled lot analysis for manufactured goods. When manufacturing occurs, the associated lots are recorded. The produced lots can likewise be placed on QC hold and the inspectors alerted to take action. Once the inspectors perform their analysis, the values of the produced goods’ lot properties would be recorded. Assuming all of the lot properties were within spec, the produced goods would be released to available inventory.

While there can be other complexities to one’s operations with packing and repacking of product into various containers with associated lots recorded, the lots shipped to a given customer would be recorded, thus providing complete visibility as to which finished goods lots were shipped to customers associated with given sales orders. This process establishes a complete chain of custody from ingredient lots received, which are consumed in manufacturing yielding manufactured lots, which are then shipped out to customers.

Once this data is recorded in the system, both forward and backward lot traceability can be performed. Forward lot traceability is the tracing of ingredients from suppliers through production processes out to customers in finished goods lots. Backward lot traceability is tracing finished goods lots back from customers into production to determine which other customers received product from those specific produced lots and back to ingredients received from suppliers, if necessary.