HANDLING THE OUT OF SPECIFICATION (OOS) RESULTS IN PHARMACEUTICAL/ BIOPHARMACEUTICAL INDUSTRIES FOR COMPLIANCE – A HOLISTIC REVIEW

Handling of written operational procedures is mandatory in pharma/biopharma industries in view of, to carry out activities for compliance. Out of all these procedures, handling of Out Of Specification (OOS) results attracted the attention of pharma/biopharma industrialists. To investigate the OOS result, an operating procedure should be in place. If any result found out of specification that should be investigated. The source of the OOS result should be identified either as an aberration of the measurement process i.e., laboratory error or an aberration of the manufacturing process. Phase I investigation (laboratory investigation) should include an initial assessment of the accuracy of the laboratory's data which may occur from instrument, reagent, reference standard, environment condition, test method, analyst and calculation within laboratory. Phase II investigation (full-scale OOS investigation) consist of a production/ user department process review and/or additional laboratory investigation. The written procedure should give guidance on the number of retests/ resamples permitted. After impact assessment of OOS on product/ process, appropriate CAPA to be initiated to avoid reoccurrences. This is the first reported and ideal form of handling the out of specification results in different pharmaceutical/ biopharmaceutical industries across the world.