Title SOP for Handling of Out of Trend (OOT).pdf ✅

PharmaInfo M-Powering ur Pharma Journey Visit this link for more Pharma related SOPs, Article and Documents: https://www.m-pharmainfo.com/ Attachment - I -- OOT INVESTIGATION FORM Date of OOT occurrence: OOT Reference No.: A. OOT REPORTING: (To be completed by analyst) Product / Material Name Control No. Batch No. Mfg. Date Specification No. Expiry Date Test Name Test Method No. Stage of testing (For Drug substance / Intermediate / Drug product) (select the applicable option)  In-process  Finished product / Intermediate release testing  Stability Months Accelerated / Long Term / Intermediate Summary of OOT Test Results (state result and specification) Details of abnormal observations noted during the testing, if any Analyst Name Signature & Date
PharmaInfo M-Powering ur Pharma Journey OOT Reference No.: B. LABORATORY INVESTIGATION : Sr. No. Check Parameters Observations (Yes/No/NA) Comments 1.0 Sampling 1.1 Any abnormal observation noted during sampling? 1.2 Any noticeable difference in sample appearance? 1.3 Sample is correctly collected & labeled? 1.4 Sample storage was done appropriately? 2.0 General 2.1 Any unusual happening in lab? (e.g. power failure) 2.2 Was the method discussed with the analyst? 2.3 Correct analytical method used? 2.4 Analyst was trained to perform the test? 2.5 Correct glassware used for dilutions? 2.6 Glassware were properly cleaned? 2.7 Instrument used are qualified? 2.8 Instruments used within calibration validity period Instrument Used (Name & ID) Calibration Due 2.9 Instrument setup & operation as per standard operating procedure? 2.10 Use of appropriate grade of chemical and reagents within the validity period? 2.11 Correct normality / molarity of volumetric solutions used? 2.12 VS used Valid up to date Strength Visit this link for more Pharma related SOPs, Article and Documents: https://www.m-pharmainfo.com/