Quality control/assurance shelf life

Once the type of packaging material is decided based on such factors as size, shape, capacity, and physicochemical properties, all these data, including quality control tests, should be included in the specification of the products in order to assure the therapeutic effectiveness during its shelf life. 

The SNS Program ensures that the medical materiel stock is rotated and kept within potency shelf-life limits. This involves quarterly quality assurance/quality control checks on all 12-hour Push Packages, annual 100% inventory of all 12-hour Push Package items, and inspections of environmental conditions, security, and overall package maintenance. 

Finally, in this section, it is useful to agree on what the minimum acceptable shelf life for the product should be. The product will need to be stable enough to allow time for quality control (QC) testing and quality assurance (QA) release after manufacture distribution to wholesalers, pharmacists and doctors and with acceptable time for storage until prescribed and used by patients. Normally, a minimum three-year shelf life at room temperature is targeted. However, if the treatment is very novel, it may be possible to justify a shorter shelf life and/or storage at lower temperatures, if stability is likely to be a problem. 

To support their high standards, sterile products require the greatest attention to detail in the quality of design stage, the highest quality standards and most effective quality assurance and quality control procedures. The fact that the seal is usually based on rubber means that the effectiveness and integrity of the total closure system has to be evaluated at several phases of the product shelf life, i.e. 

This is considered by many as the ultimate test of quality control or assurance. The only drawback with this approach is the cost of using such a panel to get reliable shelf life stability data points at every testing time interval in order to obtain a representative sensory shelf life stabihty profile which reflects changes in the rancidity of the product over time. Lipid oxidation and rancidity represent two sides of the same coin oxidation is the process, and rancidity is the perceived result (Warner and Eskin, 1995). 

---