Manufacturing Deviation Case Studies – Page 2

Critical IPC skipped during scale-up – FDA inspection observation breakdown

Signals of a potential problem can manifest as anomalies or irregularities during various manufacturing stages. In our case study, the following symptoms were noted:Click to read the full article.

Deviation recurrence across batches during tech transfer – root cause analysis failure explained

In our case study, issues arose during the technology transfer of a new sterile injectable. Multiple batches exhibited variability in key quality attributes, notably particle counts and sterility assurance levels,…

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

During the weeks leading up to a routine FDA inspection, operators at a solid oral dosage manufacturing facility noticed unexpected fluctuations in the yield of batch processes. Several batches deviated…

Process change implemented without QA approval during scale-up – CAPA ineffectiveness identified

During routine production monitoring, unexpected fluctuations in process parameters were detected in a large-scale batch of an oral solid dosage form. Specifically, operators reported that the dissolution rates were consistently…

Unapproved process parameter change during tech transfer – FDA inspection observation breakdown

The unapproved process parameter change during a tech transfer can manifest in several symptoms, both in manufacturing operations and laboratory settings. For instance:Click to read the full article.

Deviation recurrence across batches during commercial campaign – root cause analysis failure explained

The initial indicators of deviation recurrence may include:Click to read the full article.

Deviation recurrence across batches during changeover – CAPA ineffectiveness identified

During routine manufacturing, the QA team noticed an alarming trend: batch deviations related to quality attributes of both active pharmaceutical ingredients (APIs) and finished products occurred consistently during changeover periods.…

Batch executed with expired SOP during scale-up – regulatory impact assessment case study

Upon routine inspection during a scale-up operation, several alarming symptoms were noted. These included:Click to read the full article.

Batch executed with expired SOP during changeover – regulatory impact assessment case study

The initial indication of the deviation was highlighted during a routine quality control check after batch completion. The following symptoms were noted:Click to read the full article.

Batch executed with expired SOP during inspection preparation – regulatory impact assessment case study

The initial symptoms of the deviation manifested during internal audits preceding the external FDA inspection. Key signals included:Click to read the full article.

Deviation recurrence across batches during scale-up – regulatory impact assessment case study

During the scale-up phase of a new formulation designed to treat an oncology indication, operators began to observe alarming signals indicative of systemic issues. The signs included:Click to read the…

Equipment used without release during changeover – FDA inspection observation breakdown

The first signal indicating a potential issue surfaced during a routine internal audit when employees discovered that equipment had been used in the production area without proper documentation of release…