Standard operating procedure to handle the out of specification results during the analysis of Pharmaceutical products and its investigation report during different stages.
OOS (Out of Specification) refers to a product that does not meet the established specifications as expected. OOS investigation determines the actual cause of the results.
In this type of situation, the entry of any microorganisms into the sampling process is most likely to occur, either during the procedure (when the sampling bag and ultrafiltration/diafiltration [UF/DF] pool bag are assembled) or as a result of inadequate sampling procedures. Review of relevant...