Tolerability to GLP-1 receptor agonists can be limited by gastrointestinal events, and starting at a low dose with slow titration is recommended. The role of NPY in appetite control can be demonstrated by central administration of NPY which results in a markedly increased desire for food intake. Separate logs should be maintained by Quality Assurance for change control depending upon the type of change. The glassware used for analysis should be of appropriate quality and capacity. Confirmed failures out of repeat analysis and out of specification investigations. Product failures should be promptly reported to Unit Head, regulatory affairs, R & D, Quality Assurance, and customer (if applicable) for necessary action. Product Shelf life extension/reduction. In-process and finished product sampling testing related. A documented on-going testing program should be designed to monitor the stability of each product and the results should be used to confirm appropriate storage conditions and retest/expiry dates.

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