Expiry dating for reagents and solutions in laboratories what are fda expectations

Expiry dating for reagents and solutions in laboratories what are fda expectations

expiry dating for reagents and solutions in laboratories what are fda expectations
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Documentation and Records: Harmonized GMP Requirements













































Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future.
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If the manufacturer suggests an expiry date, that date should be followed. The FDA expects an assessment to be performed for purchased laboratory reagents without expiry date indicated by the manufacturer.

This decision is made based on the stability of the solution, its intended use and storage conditions. If this information is not stated in the text in a USP monograph for the particular volumetric solution, then it is up to your lab to define this frequency. You need to have experimental data to support your decision. Do not assume arbitrary frequencies. If this information is not stated in the text in a USP monograph for the particular solution, buffer, etc.

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