PRODUCT TYPES – Page 18

Assay drift after equipment cleaning: FDA/EMA investigation expectations

The first step in addressing assay drift after equipment cleaning is to recognize the symptoms or signals that indicate an issue. Common manifestations include:Click to read the full article.

Finished product blend uniformity failure during PAI / FDA inspection readiness: data integrity review steps for LIMS/EMR/ES and chromatography systems

Blend uniformity failures manifest through various signals that can be observed both on the manufacturing floor and within laboratory settings. Identifying these symptoms promptly can prevent cascade failures within the…

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…

Finished product serialization data mismatch during routine batch release: how to build a deviation package that passes an inspection deep-dive

Symptoms of a serialization data mismatch can manifest in several ways, such as:Click to read the full article.

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.

Finished product impurity increase on stability during stability pull at accelerated conditions: CAPA plan that inspectors accept (with effectiveness checks and due dates)

When engaging in stability studies, especially under accelerated conditions, various symptoms can signal potential quality issues. The most prominent concerns 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…

Finished product hardness / friability drift during complaint trending review: how to defend specification setting and outlier handling during inspection

Identifying the right signals is the first step in any investigation. In the context of hardness and friability, the following symptoms may indicate underlying problems:Click to read the full article.

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…

Finished product coating non-uniformity during PAI / FDA inspection readiness: how to build a deviation package that passes an inspection deep-dive

Identifying symptoms that indicate coating non-uniformity is crucial to initiating a proper investigation. Symptoms can manifest both visually and through analytical testing methods. Some key signals to look out for…

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…

Finished product stability trend (OOT) during stability pull at accelerated conditions: stability strategy adjustments and packaging risk mitigation steps

Recognizing the symptoms of an OOT stability trend is crucial for timely intervention. Key signals include:Click to read the full article.