Deviation Case Studies – Page 6

Process change implemented without QA approval during changeover – root cause analysis failure explained

The initial indication of a potential issue arose during the quality control testing phase, where batch samples from a recent changeover period displayed out-of-specification (OOS) results. The specific symptoms noted…

Batch executed with expired SOP during tech transfer – CAPA ineffectiveness identified

The initial detection of the issue occurred through routine quality checks during the technology transfer process. Key symptoms included:Click to read the full article.

Equipment used without release during inspection preparation – regulatory impact assessment case study

During a routine FDA inspection at a pharmaceutical manufacturing facility, inspectors identified the use of a piece of equipment that had not received proper release documentation. The symptoms included:Click to…

Deviation recurrence across batches during tech transfer – CAPA ineffectiveness identified

Upon the initiation of a technology transfer, operators noticed that several batches of product consistently exhibited deviations in key quality attributes. Symptoms included out-of-specification (OOS) results for potency and impurity…

Process change implemented without QA approval during routine manufacturing – CAPA ineffectiveness identified

In this scenario, the first signals of deviation were detected through routine quality control checks. The following symptoms were notably observed:Click to read the full article.

Process change implemented without QA approval during routine manufacturing – FDA inspection observation breakdown

The first indication of a potential issue was a sudden uptick in deviations reported during routine quality checks of a newly manufactured batch of product X. Quality Control (QC) analysts…

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…