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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.