Packaging & Labeling Deviations – Page 2

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.

Packaging deviation repeated during inspection – regulatory reporting outcome

During a routine FDA inspection of a commercial pharmaceutical packaging facility, inspectors identified recurring packaging deviations that had been documented over the previous three months. The deviations mainly revolved around…

Packaging deviation repeated during packaging operations – CAPA ineffectiveness analysis

Analyzing Repeated Packaging Deviations in Pharmaceutical Operations In the realm of pharmaceutical manufacturing, maintaining stringent quality standards is paramount. A case recently observed in a contract packaging facility highlighted significant…

Label reconciliation failure during deviation review – recall risk case study

The scenario began when the quality control (QC) team noticed discrepancies in the batch records during routine documentation audits. Specific symptoms included:Click to read the full article.

Incorrect artwork version used during deviation review – recall risk case study

During a scheduled review, quality control (QC) personnel noted several discrepancies in the artwork attached to a batch of medication packaging. Symptoms included:Click to read the full article.

Tamper seal deviation during inspection – regulatory reporting outcome

During a routine inspection, quality control (QC) team members noticed that several tamper-evident seals on the packaging of a finished goods batch were not adhering correctly. The findings included:Click to…

Packaging deviation repeated during deviation review – recall risk case study

The initial detection of the packaging deviation was made through several signals observed on the production floor. Key symptoms included:Click to read the full article.

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

The initial detection of the line clearance failure occurred during a routine quality check when a batch of packaged products was identified with incorrect labeling. Symptoms included:Click to read the…

Packaging deviation repeated during inspection – recall risk case study

During a recent FDA inspection, a major pharmaceutical manufacturer identified deviations in the packaging line handling a popular over-the-counter medication. The symptoms observed included:Click to read the full article.