Author(s): SEETHA RAM KOTRA, SURESH CHAVVAKULA, PARDHASARADHI MATHI, MUTYALA RAO CHANDA, YATHISH M THIMMAREDDY, DEVA MALLESWARAIAH, SANDEEP PATHAK, ANJALI KUMARI CHILLARA, VENUGOPALA RAO PULI, JAWAHAR BABU PERAVALI
Following the written and operational procedures are mandatory in pharma/ biopharma industries in view of cGMP and to carry out activities for compliance. OOS handling is critical in quality perspective, as invalid OOS is a point of concern by different regulatory authorities. To investigate the OOS result, an operating procedure should be in place. If any result found out of specification, that should be investigated through this procedure. 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) aims at ruling out any laboratory/ equipment error (which may occur due to instrument, reagent, reference standard, environment condition, test method, analyst and calculation). Phase II investigation (fullscale OOS investigation) consists of a production department for process review. Additional laboratory investigation shall be carried out by production including the cross functional teams if any, if required. The procedure also provide guidance on the number of retests/ resamples permitted. After impact assessment of OOS on product, appropriate corrective action and preventive action (CAPA) shall be proposed to avoid the occurrence in future. This is the first review reported and ideal form of handling the OOS results in any pharmaceutical/ biopharmaceutical industries across the world.
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