Deviation Case Studies – Page 6

Unplanned hold time extension during inspection preparation – regulatory impact assessment case study

Upon receiving notice of an impending regulatory inspection, the Quality Control (QC) lab noted inconsistencies in the sample preparation process. Specifically, multiple batches prepared for sample analysis exhibited an extended…

Deviation recurrence across batches during tech transfer – FDA inspection observation breakdown

During the tech transfer of a complex biologic product, several symptoms arose across batch production. Key signals included:Click to read the full article.

Unapproved process parameter change during tech transfer – regulatory impact assessment case study

In our case study involving the tech transfer of a biopharmaceutical product, the symptoms indicating an issue were first observed during batch production. Operators noted deviations in critical quality attributes…

Unapproved process parameter change during commercial campaign – root cause analysis failure explained

The situation began to unfold when operators noticed a higher-than-expected variability in the potency of the batch produced with altered settings in the granulation phase. Alerts from the in-line monitoring…

Unplanned hold time extension during changeover – regulatory impact assessment case study

During an internal audit, the quality assurance team identified discrepancies in the batch processing record that indicated an extended hold time during the changeover between two production runs. This was…

Critical IPC skipped during scale-up – CAPA ineffectiveness identified

Early detection of manufacturing deviations is essential for minimizing potential impacts on product quality. In the case at hand, multiple symptoms indicated a serious issue shortly after the scale-up was…

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…