Batch Rejection

Several reasons can lead to the rejection of a pharmaceutical batch: Microbial Contamination: Presence of harmful bacteria, fungi, or other microorganisms, especially in sterile products. Out-of-Specification (OOS) Results: Test results, such as potency, dissolution, or assay, falling outside the set quality parameters. Deviations in Manufacturing Process: Unplanned changes or errors during production, such as incorrect…