Hardness drift after scale-up – FDA inspection observation risk
Identifying the symptoms of hardness drift is the first step in any investigation. Common indicators include:Click to read the full article.
Manufacturing Defects
Disintegration time failure after tooling change – process vs formulation assessment
The first step in addressing disintegration time failures is recognizing the symptoms or signals that indicate a potential problem. Common indicators in the laboratory or manufacturing floor may include:Click to…
Friability failure during campaign changeover – CAPA failure identified
Recognizing the early symptoms of friability issues is essential for timely intervention. Indicators of friability problems may include:Click to read the full article.
Weight variation failure during campaign changeover – process vs formulation assessment
Identifying operational symptoms of weight variation failure during campaign changeovers often requires keen observation and systematic reporting. Symptoms may manifest in operational data or product inspection results, including:Click to read…
Friability failure during compression – root cause analysis breakdown
Identifying symptoms that indicate potential friability failure during the compression of tablets is crucial for timely intervention. Symptoms may include:Click to read the full article.
Weight variation failure during stability pull – process vs formulation assessment
Weight variation failures typically manifest as discrepancies in tablet weights outside the specified range during stability testing. Signals to watch for in both the manufacturing environment and the laboratory include:Click…
Tablet lamination defect during high-speed runs – CAPA failure identified
Detecting tablet lamination defects requires vigilance and a keen eye on the production floor. Some common symptoms and signals that point to potential issues include:Click to read the full article.
Tablet lamination defect during high-speed runs – root cause analysis breakdown
Identifying the symptoms of tablet lamination defects early can mitigate the impact on production. Common signals include:Click to read the full article.
Tablet capping observed during high-speed runs – CAPA failure identified
Identifying the signs of tablet capping is essential for timely intervention. Manufacturing staff may observe the following symptoms:Click to read the full article.
Content uniformity OOS during high-speed runs – CAPA failure identified
Detection of content uniformity OOS is often triggered by several key symptoms or signals in both the manufacturing and laboratory environments. The following are common indicators that may suggest deeper…
Content uniformity OOS after tooling change – FDA inspection observation risk
Detecting a deviation in content uniformity can manifest through various symptoms on the manufacturing floor or in the quality control laboratory. Key signals include:Click to read the full article.
Sticking and picking during compression – process vs formulation assessment
Identifying symptoms is the first step in recognizing manufacturing defects associated with sticking and picking during tablet compression. Symptoms may become apparent directly on the production floor or through quality…