Abstract :
To conduct an effective failure investigation, we need to review in details to hit the root cause.There are different areas to initiate with the investigation depending upon the nature of the failure and accordingly investigation is carried out.InvestigationAnalytical: Confirmed Out of Specification.Material:Qualification status of Vendors & review of test result of raw material/ packing material, Storage of Raw materials/ Packing materials & Deviation during Receipt/ Storage. Storage, Transportation and distribution of Finished Product.Dispensing of Raw material/ Packing material: Line clearance procedures, Environmental condition and Deviation for/ during Dispensing. Review of Dispensing of Raw Material/ Packing material. Calibration status of Dispensing Balances and Qualification of the Personnel. Manufacturing/ Packing:Line clearance procedures and Environmental condition for/ during manufacturing/ Packing. Review of Batch Manufacturing / Packing process and Process Validation of the product. Qualification, Calibration, Preventive maintenance and cleaning status of the equipments involved. Qualification/ training of the personnel involved in the Manufacturing/ Packing operation. Deviation/Non conformance during the Batch Manufacturing/ Packing.Utilities and System:Review of the utilities and system involved in the manufacturing of the product. Deviation/Non conformance in the utilities and system.Evaluation of Sample:Evaluation (Physical & Chemical) of Control samples and defective product received.Quality System:Review of Deviation, Changes and stability test results associated with the product. Historical trend (Compliant/Recall/Failure).Others:Impact on other batch/Product. Others, if any, which may cause the failure.
Keyword :
Investigation of Failure, Batch Failure, Failure, Manufacturing Process Investigation and Investigation