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Off-specification investigations in pharmaceuticals have many advantages. Out-of-specification investigations can help identify product defects and manufacturing defects, which can lead to improved efficiency and quality control. Additionally, specifications can help identify potential new markets for a product beyond the investigation.
If conducted properly, out-of-specification investigations can provide valuable information that can be used to improve manufacturing processes and increase product quality. By investigating products that fall outside their specified limits, manufacturers can avoid customer dissatisfaction or environmental damage.
There are many factors to consider when conducting out-of-specification investigations. First, it is important to identify the products that need to be investigated Second, it is necessary to determine the specific range within which the products should fall. Third, it is necessary to determine whether any corrective action needs to be taken. Fourth, results need to be tracked and adjusted as needed. Finally, it is important to report results and lessons learned so that future products can be developed with accuracy and precision.
