Oncology Products – Page 4

Potency OOS during shared facility campaign: risk assessment for patient safety

When potency OOS results arise during manufacturing, various symptoms or signals may indicate underlying issues. These signals can be both immediate and subtle. Recognizing these symptoms quickly is crucial for…

Assay drift during inspection prep: FDA/EMA investigation expectations

The initial signals of assay drift can often manifest in a variety of ways within both laboratory and manufacturing settings. Key symptoms may include:Click to read the full article.

Potency OOS in oncology manufacturing: FDA/EMA investigation expectations

Recognizing the symptoms and signals indicating a potential potency OOS situation is the first step in the investigation process. These signals may arise during routine testing, batch release, or even…

Assay drift after equipment cleaning: containment CAPA and effectiveness checks

Identifying symptoms of assay drift after equipment cleaning is the first crucial step in addressing the problem. Some common signals to look out for on the manufacturing floor or in…

Occupational exposure limit breach during inspection prep: FDA/EMA investigation expectations

Recognizing signs of an occupational exposure limit (OEL) breach is the first step in the investigation process. Symptoms may vary depending on the specific products being handled; however, certain indicators…

Occupational exposure limit breach during inspection prep: risk assessment for patient safety

Identifying the symptoms or signals that indicate an OEL breach is critical for timely interventions. The signals may include:Click to read the full article.