Moisture ingress detected during stability testing – device vs formulation investigation
Detecting moisture ingress is critical for maintaining the stability of a DPI. Symptoms may include:Click to read the full article.
Manufacturing Defects
Device assembly defect during DPI filling – CAPA control strategy gap
Identifying the initial symptoms is crucial for effective investigation. In a DPI filling operation, various symptoms may indicate a device assembly defect:Click to read the full article.
Capsule puncture failure during DPI filling – device vs formulation investigation
Identifying symptoms that indicate a capsule puncture failure during DPI filling is the first step of the investigative process. Symptoms may vary based on the severity of the defect but…
Moisture ingress detected during DPI filling – CAPA control strategy gap
Detecting moisture ingress during DPI filling may manifest through various symptoms and signals that indicate potential quality issues:Click to read the full article.
Fine particle fraction drift during stability testing – CAPA control strategy gap
Identifying symptoms or signals from either the manufacturing floor or quality control laboratory is essential for contrasting expected outcomes with actual results. In the case of fine particle fraction (FPF)…
Delivered dose uniformity failure during DPI filling – device vs formulation investigation
Identifying symptoms or signals is the first step in investigating delivered dose uniformity failures. Common signals include:Click to read the full article.
Powder flow issue after device change – device vs formulation investigation
Detection of powder flow issues can manifest through various signals in the manufacturing process. Common symptoms to look for include:Click to read the full article.
Delivered dose uniformity failure during inspection readiness – regulatory expectation mismatch
When evaluating DDU failures, the first objective is to identify relevant symptoms and signals early in the manufacturing or laboratory environment. Signals may manifest as:Click to read the full article.
Capsule puncture failure during stability testing – regulatory expectation mismatch
Identifying signals indicative of capsule puncture failures is crucial for timely intervention and effective investigation. Key symptoms can manifest in various ways:Click to read the full article.
Edge lifting observed during storage – process vs material root cause
The immediate recognition of edge lifting occurrences can often prevent larger quality issues from developing. Symptoms may include:Click to read the full article.
Adhesion failure during storage – inspection finding risk
Identifying symptoms or signals of adhesion failure is the first step in managing potential product defects. Common indications might include:Click to read the full article.
Patch curling during patch manufacturing – CAPA documentation failure
Identifying symptoms of patch curling is crucial for initiating prompt investigation and containment actions. Symptoms may vary based on the specific formulation or production stage, but some common signals include:Click…