Deviation & Failure Case Studies – Page 18

Worst-case selection unjustified during multi-product manufacturing – cross-contamination risk case study

Cross-contamination is often first detected through various signals on the production floor or in laboratory testing that deviate from the norm. In our case study, the following symptoms were noted:Click…

Document revisions uncontrolled during deviation investigation – inspection citation risk explained

In the early stages of the deviation investigation, several symptoms arose that indicated potential documentation control issues. During a routine quality control audit, the quality assurance team observed that revisions…

Personnel not trained on revised SOP during QA review – CAPA and training system breakdown

Signs of the training deficiency began emerging during routine QA reviews. These symptoms included:Click to read the full article.

GDP errors repeated during inspection – inspection citation risk explained

During a routine inspection by the FDA, it was observed that several critical deviations in GDP occurred, such as inconsistent date entries, missing signatures, and improperly completed batch records. These…

GDP errors repeated during deviation investigation – CAPA and training system breakdown

In the reported case, several symptoms indicated significant issues within the documentation processes. These symptoms included:Click to read the full article.

GDP errors repeated during deviation investigation – inspection citation risk explained

Symptoms of GDP errors typically manifest in various forms during daily operations. In the illustrative case at a mid-sized pharmaceutical manufacturing facility, repeated non-conformance was identified following internal audits and…

GDP errors repeated during inspection – QMS remediation failure

The observation of GDP errors can manifest in several ways during routine operations. In this case study, the following symptoms were reported:Click to read the full article.

Training records completed after deviation during QA review – inspection citation risk explained

In a recent incident at a pharmaceutical manufacturing facility, adverse symptoms were observed in the quality control lab related to a batch of injectable products. Operators reported inconsistencies in the…

GDP errors repeated during audit – CAPA and training system breakdown

The audit revealed a pattern of repeated discrepancies within the GDP framework, including:Click to read the full article.

Personnel not trained on revised SOP during deviation investigation – inspection citation risk explained

The initial detection of the issue began when a deviation was reported during the batch production process. This manifest as frequent errors in data logging, irregularities in batch production records,…

Document revisions uncontrolled during audit – inspection citation risk explained

The incident began when a routine FDA inspection identified several instances where document revisions were not adequately controlled. Symptoms of this issue included:Click to read the full article.

Training effectiveness not assessed during deviation investigation – CAPA and training system breakdown

Detection of training deficiencies often surfaces during routine audits or through supervisory observations. In this instance, the symptoms included:Click to read the full article.