Deviation Case Studies – Page 5

Unapproved process parameter change during commercial campaign – FDA inspection observation breakdown

During routine production of a critical biopharmaceutical product, several symptoms emerged which indicated a potential deviation from established practices. Operators noted inconsistencies in batch quality, evidenced by out-of-specification (OOS) results…

Batch executed with expired SOP during commercial campaign – root cause analysis failure explained

Upon execution, the manufacturing team observed several warning signals that indicated the use of an expired SOP:Click to read the full article.

Deviation closed without effectiveness check during changeover – FDA inspection observation breakdown

During routine operational monitoring on the production floor, the quality assurance team noted several irregularities that triggered an investigation. The signals included:Click to read the full article.

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

Case Study: Impact of Unapproved Process Change during Routine Manufacturing In a recent incident at a pharmaceutical manufacturing facility, a process change was implemented without the necessary Quality Assurance (QA)…

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

During routine quality control checks, operators noticed discrepancies in product consistency, leading to out-of-specification (OOS) results. Specifically, the following signals were detected:Click to read the full article.

Equipment used without release during routine manufacturing – FDA inspection observation breakdown

The operational team identified deviations when a routine batch was prepared for release testing. Symptoms included:Click to read the full article.

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…