This SOP establishes procedures for documenting and investigating out-of-specification (OOS) test results, to determine whether the OOS result is an accurate reflection of the lot or batch (i.e., is a valid test result) or is a result of laboratory or sampling error (i.e., is an invalid test result).

OOS investigations are not required by 21 CFR 111. However, it is a good business practice to conduct an OOS investigation whenever an OOS test result is found, because it would be unwise to base important and potentially expensive business decisions on data which might be erroneous.

This SOP is written with the assumption that the company has an in-house laboratory and also outsources some tests to outside labs. If the company relies solely on contract laboratories, the SOP can be modified appropriately. Reputable contract laboratories are usually willing and able to help with an OOS investigation, although if extensive investigation or additional analyses are required the lab may charge for the additional costs.

This SOP is written for a dietary ingredient or supplement company. Its provisions are in certain respects different from those required of drug companies.]

The report can be used to document OSS investigations.

The log can be used to track OOS investigations. Whenever a test of examination yields results which do not meet specifications, an OOS investigation should be conducted to determine whether the result is valid or is due to testing or sampling error. This investigation is not explicitly required by dietary supplement GMPs, but it is always wise to ensure any OOS test result is a valid one rather than deciding the disposition of ingredients or product based on faulty data. Details about each OOS investigation should be recorded on an Out-Of-Specification Report.