Manufacturing Defects – Page 2

Injectable Defects Like Visible Particles? Sterile Process Fixes and Controls

Identifying defects in injectable products often begins with recognizing signals on the manufacturing floor or in quality control labs. Common symptoms of visible particle contamination may include the following:Click to…

DPI Performance Failures? Particle Size, Blending, and Device Fixes

Detecting DPI performance failures often begins with observational signals from manufacturing or quality control teams. Common symptoms signaling possible DPI defects include:Click to read the full article.

Patch Defects Like Lifting and Dose Drift? Adhesive and Release Fixes

Identifying symptoms of transdermal patch defects promptly allows for swift corrective action. Symptoms on the manufacturing floor or in the quality control laboratory may include:Click to read the full article.

Tablet capping observed during high-speed runs – process vs formulation assessment

Identifying symptoms or signals of tablet capping is essential for proactive resolution. Common indicators include:Click to read the full article.

Disintegration time failure during high-speed runs – FDA inspection observation risk

Identifying symptoms early in the manufacturing process is crucial in mitigating the risk of disintegration time failures. Observations may include:Click to read the full article.

Tablet chipping complaint after tooling change – process vs formulation assessment

Identifying symptoms is the first step in addressing a manufacturing defect. In the case of tablet chipping, several signals may be observed:Click to read the full article.

Weight variation failure during campaign changeover – FDA inspection observation risk

Recognizing the early signs of weight variation failures is crucial for timely intervention. Symptoms may include:Click to read the full article.

Disintegration time failure during high-speed runs – root cause analysis breakdown

The first step in addressing a disintegration time failure during high-speed runs is recognizing the symptoms that may indicate a problem. Symptoms can be identified both in production environments and…

Sticking and picking after tooling change – CAPA failure identified

The initial identification of sticking and picking can occur during several stages of the tablet manufacturing process. The following symptoms should alert manufacturing and quality control personnel:Click to read the…

Tablet lamination defect during campaign changeover – process vs formulation assessment

The first step in addressing a tablet lamination defect involves recognizing the symptoms that indicate a potential issue. Symptoms can manifest during various stages of tablet production and may include:Click…

Tablet lamination defect after tooling change – root cause analysis breakdown

Analyzing Tablet Lamination Defects Following Tooling Changes In pharmaceutical manufacturing, discrepancies can significantly impact quality control (QC) and overall product efficacy. One common concern is a tablet lamination defect observed…

Tablet chipping complaint after scale-up – root cause analysis breakdown

Symptoms indicative of a tablet chipping complaint can manifest in various ways, including:Click to read the full article.