Deviation Case Studies – Page 7

Unapproved process parameter change during inspection preparation – FDA inspection observation breakdown

During routine reviews of batch production records (BPRs) in preparation for an upcoming FDA inspection, a Quality Assurance (QA) manager noticed discrepancies related to process parameters documented versus those observed…

Batch executed with expired SOP during changeover – FDA inspection observation breakdown

The initial indications of the deviation arose during a routine quality control check after the execution of a batch of a critical pharmaceutical product. The following symptoms became apparent:Click to…

Equipment used without release during commercial campaign – FDA inspection observation breakdown

The first indication of potential deviation often arises from observing unusual patterns or anomalies during the production process. In this case, operators reported discrepancies in batch records and equipment usage…

Equipment used without release during tech transfer – CAPA ineffectiveness identified

In this case, the first indication of a problem was noticed during a routine production review when a quality control (QC) analyst flagged an anomaly in batch records. It became…

Critical IPC skipped during routine manufacturing – root cause analysis failure explained

In the incident described, the initial symptoms that indicated a problem occurred during the final batch review process of a sterile injectable product. The following signals were identified:Click to read…

Critical IPC skipped during changeover – root cause analysis failure explained

The incident began when a routine quality control audit identified a missing record for a critical IPC during a product changeover. The IPC, which was intended to verify both cleanliness…

Batch executed with expired SOP during routine manufacturing – FDA inspection observation breakdown

The initial detection of the deviation stemmed from QA's routine document review process. Key symptoms included:Click to read the full article.

Process change implemented without QA approval during changeover – regulatory impact assessment case study

During routine production monitoring, operators reported an unexpected increase in out-of-specification (OOS) results for a particular batch. Key symptoms included:Click to read the full article.

Unauthorized method modification during stability analysis – CAPA failure exposed

Upon routine compliance checks, a laboratory analyst observed deviations in the stability results of an important product. Specific signals included:Click to read the full article.

Backdated test records during method transfer – data integrity breach analysis

The initial identification of issues begins in the QC lab. In this case, the alarm was raised by a laboratory technician who noticed inconsistencies between the recorded data for method…

OOS invalidated without justification during investigation – CAPA failure exposed

The initial sign of the issues at hand came when the quality control (QC) laboratory received test results indicating that a batch of solid dosage forms had failed the dissolution…

System suitability failure ignored during method transfer – CAPA failure exposed

In this case, symptoms of a system suitability failure became evident as laboratory personnel began executing planned method transfers. The following signals were observed:Click to read the full article.