Dosage Forms & Drug Delivery Systems – Page 21

Adhesion Failure during lamination: process parameter review and validation impact

Identifying early symptoms of adhesion failure during the lamination process is crucial to prevent widespread issues. Common signals include:Click to read the full article.

Phase Separation in cream manufacturing: GMP investigation and CAPA strategy

Detection of phase separation can occur at various stages during cream manufacturing. Common symptoms include:Click to read the full article.

Edge Lifting at accelerated stability: GMP investigation plan and CAPA

Identifying edge lifting early in the manufacturing or quality control process is crucial. Common symptoms or signals indicating potential issues include:Click to read the full article.

Cleaning Validation Failure during method transfer: cleaning validation and worst-case selection

The initial signs of a cleaning validation failure may surface in various forms, often requiring prompt detection and action. Some symptoms to monitor include:Click to read the full article.

Edge Lifting during die-cutting: root cause mapping across materials and process

Before delving into the potential causes of edge lifting during die-cutting, it's essential to recognize the symptoms or signals that indicate a problem. These can manifest in various forms:Click to…

Ccit Failure during sterile filtration: risk assessment for sterility assurance

Identifying symptoms or signals of CCIT failure during sterile filtration is crucial for prompt mitigation. Key indicators include:Click to read the full article.

Curling After Packaging after adhesive change: process parameter review and validation impact

When curling occurs after packaging involving adhesive changes, certain symptoms can be observed that signal a deeper issue within the production process. Common indicators include:Click to read the full article.

Viscosity Drift during method transfer: how to document deviations for FDA/EMA

Recognizing the symptoms of viscosity drift is essential in ensuring that production runs smoothly and meets specified guidelines. Key signals that may indicate a viscosity problem include:Click to read the…

Adhesion Failure in transdermal patch manufacturing: inspection-ready documentation pack

Identifying the symptoms of adhesion failure is the first step in addressing the issue. Symptoms may not always be readily apparent during the assembly of transdermal patches but can manifest…

Viscosity Drift during shared equipment campaign: GMP investigation and CAPA strategy

Viscosity drift can manifest in various ways during production processes, particularly in shared equipment campaigns where materials and formulations change frequently. Key symptoms or signals include:Click to read the full…

Fill Volume Variability during method transfer: sampling, filtration, and EM controls

The first step in addressing fill volume variability is identifying the symptoms or signals indicative of a problem. These can include:Click to read the full article.

Residual Solvent Oos during lamination: GMP investigation plan and CAPA

The first step in addressing a residual solvent OOS incident during the lamination process is recognizing the symptoms or signals that indicate a potential problem. Common signals include:Click to read…