Reasons of Pharmaceutical 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 mixing times, temperatures, or equipment failures.
Particulate Contamination: Presence of foreign particles, such as dust, metal, or plastic, in the final product.
Packaging Issues: Defective or incorrect packaging, such as improper sealing, labeling errors, or wrong package inserts.
Stability Failures: The product does not maintain its intended quality, safety, or efficacy over its shelf life.
Improper Storage Conditions: Exposure to temperatures or humidity outside recommended ranges during production or storage.
Cross-Contamination: Unintentional mixing of different drug products or active ingredients during production.
Equipment Malfunctions: Failures or malfunctions in production equipment, leading to inconsistent batch quality.
Inadequate Cleaning: Failure to clean equipment properly, leading to contamination or residue from previous batches.
These issues compromise product quality, patient safety, and regulatory compliance.
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Resource Person: Lina Amro
