Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOIn-process controlChecks performed during production in order to monitor and, if necessary, to adjust theprocess, including repeating a process step, to ensure that the process performs as expected.The monitoring of the environment or utilities may also be regarded as part of the in-processcontrol.InspectionActivity such as measuring, examining, testing or gauging one or more characteristics of anentity and comparing the results with specified requirements in order to establish whetherconformity is achieved for each characteristic.IntermediatePartly processed material which must undergo further processing before it becomes an API.ManufactureAll operations from purchase of materials and products, through production, quality control,release and storage, to distribution of API’s, and the related controls.MaterialsA general term for raw materials, process aids, intermediates, API and packaging materials.NonconformityNonfulfillment of specified requirement.Packaging materialsAny material used to protect an API during storage and transport, but excluding labels.Preventive ActionAction taken to eliminate the causes of a potential nonconformity, defect, or other undesirablesituation in order to prevent occurrence.8