Deviation & Failure Case Studies – Page 10

Label reconciliation failure during artwork change – CAPA ineffectiveness analysis

In this incident, the first signs of the label reconciliation failure were detected during the final quality control checks prior to product release. During the review of labels against the…

Incorrect artwork version used during inspection – CAPA ineffectiveness analysis

Analysis of CAPA Ineffectiveness Due to Incorrect Artwork Version During Inspection In the highly regulated pharmaceutical industry, any deviation from established protocols can have significant repercussions. A recent incident involving…

Packaging deviation repeated during artwork change – regulatory reporting outcome

The packaging deviation was first identified through multiple complaints from the quality control (QC) team regarding discrepancies between the approved artwork and the printed materials. These symptoms included:Click to read…

Label reconciliation failure during deviation review – regulatory reporting outcome

During a routine review of batch documentation for a sterile injectable product, the Quality Control (QC) department noted discrepancies in the label reconciliation process. The following symptoms were observed:Click to…

Serialization mismatch detected during deviation review – regulatory reporting outcome

The detection of a serialization mismatch initiated through routine quality control checks revealed discrepancies in the product's batch information. Symptoms observed included:Click to read the full article.

Packaging deviation repeated during inspection – CAPA ineffectiveness analysis

The initial signs of the packaging deviation surfaced during scheduled quality assurance audits, where several batches of a recent product lines were flagged for quality discrepancies, particularly with label accuracy…

Serialization mismatch detected during packaging operations – recall risk case study

The first indication of a serialization mismatch at the manufacturing site occurred when the Quality Control (QC) team identified discrepancies in the scanned barcodes during final packaging line audits. Operators…

Line clearance failure causing mix-up during inspection – CAPA ineffectiveness analysis

The first indication of the line clearance failure came during an operational audit where discrepancies were noted among batch records and visual inspections. Production staff reported that:Click to read the…

Line clearance failure causing mix-up during artwork change – regulatory reporting outcome

The initial symptoms of the line clearance failure were observed during the packaging operation when operators noticed discrepancies between the artwork specification sheets and the labels loaded on the filling…

Label reconciliation failure during packaging operations – CAPA ineffectiveness analysis

During the routine quality control checks prior to product release, personnel noted discrepancies in the number of packaged products versus the number of labels available. Specifically, 500 units were packaged…

Incorrect artwork version used during deviation review – regulatory reporting outcome

Identifying deviations early on is crucial in maintaining compliance and ensuring product quality. In our case study, the following symptoms were observed:Click to read the full article.

Incorrect artwork version used during artwork change – recall risk case study

Detection of an issue involving incorrect artwork often occurs through several symptoms:Click to read the full article.