Dosage Forms & Drug Delivery Systems – Page 10

Hold Time Bioburden Rise during scale-up: water system and sanitation checks

The first step in addressing hold time bioburden rises is identifying symptoms or signals that indicate a potential issue. These symptoms can manifest both at the manufacturing floor level and…

Fill Volume Variability after temperature excursion: manufacturing vs lab root cause decision tree

The initial indicators of fill volume variability can manifest in various ways during production or testing. Operators and quality control personnel may observe discrepancies in fill volumes that deviate from…

Homogeneity Failure after supplier change: water system and sanitation checks

Identifying symptoms of homogeneity failures is critical for initiating an investigation. Symptoms may manifest as off-specification results during quality control (QC) testing or fluctuations in product performance. Primary signals indicating…

Preservative Under-Dosing during method transfer: manufacturing vs lab root cause decision tree

The first step in addressing an incident of preservative under-dosing is to identify the symptoms and signals that may indicate a deviation. Symptoms can manifest both on the manufacturing floor…

Crystallization In Syrup after supplier change: water system and sanitation checks

The investigation into crystallization in syrup begins with the initial signals observed either during the manufacturing process or in the quality control laboratory. Symptoms may include:Click to read the full…

Homogeneity Failure after supplier change: how QA should write CAPA for inspectors

The first step in addressing a homogeneity failure post-supplier change is to recognize the symptoms presented in the manufacturing or quality control (QC) environments. Common signals include:Click to read the…

Hold Time Bioburden Rise at accelerated stability: packaging and transport risk assessment

The first step in addressing a bioburden rise during accelerated stability studies is to identify the symptoms or signals that indicate an issue. Here are common signals on the floor…

Preservative Under-Dosing during filling line setup: manufacturing vs lab root cause decision tree

Identifying the early symptoms of preservative under-dosing during filling line setup is critical for timely intervention. Symptoms may manifest as:Click to read the full article.

Density Mismatch in oral suspension manufacturing: investigation flowchart aligned to GMP

Recognizing symptoms of density mismatch is the first step in tackling the issue effectively. Common signals include:Click to read the full article.

Homogeneity Failure during scale-up: mixing, sampling, and hold-time controls

Detecting a homogeneity failure often begins with observing symptoms in the manufacturing process or quality control laboratory. Common signals may include:Click to read the full article.

Ph Drift after supplier change: packaging and transport risk assessment

The detection of pH drift following a supplier change often manifests through several clear signals that pharmaceutical professionals should be vigilant about:Click to read the full article.

Color Change On Stability during bulk hold: mixing, sampling, and hold-time controls

Identifying symptoms of color changes during stability evaluations involves keen observation and measurement. The following signals should be monitored closely:Click to read the full article.