Dosage Forms & Drug Delivery Systems – Page 3

Dental Product Performance Problems? Fixes for Consistency, Stability, and Release

Performance problems in dental dosage forms may display a range of symptoms that signal the need for immediate investigation. These symptoms can manifest either on the manufacturing floor or within…

Novel Delivery Systems Not Meeting Targets? Practical Development and Scale-Up Solutions

In the context of developing and scaling novel drug delivery systems, various signals or symptoms may indicate that targets are not being met. These can manifest as inconsistent product quality…

Combination Product Failures at Interface? Quality and Regulatory Solutions

Addressing Failures in Combination Drug Products: Quality and Regulatory Approaches Combination drug products involve the integration of a drug with a device or biological product, presenting unique challenges in manufacturing…

Sticking And Picking after excipient change: sampling plan fixes to avoid repeat OOS

The identification of sticking and picking issues relies on meticulous observation and signal detection. Symptoms may manifest as:Click to read the full article.

Capsule Shell Brittleness during compression: GMP investigation steps and batch disposition

Detecting symptoms is the first step in addressing brittleness in capsule shells during compression. This often manifests through various signals, either on the production floor or within quality control laboratories.…

Oot Dissolution Trend in multi-strength campaign: GMP investigation steps and batch disposition

When dissolution trends deviate from established norms, specific signals may manifest within the production environment. Typical symptoms to monitor include:Click to read the full article.

Sticking And Picking during FDA inspection readiness: GMP investigation steps and batch disposition

Identifying symptoms of sticking and picking early on is crucial for ensuring prompt investigation and response. Sticking refers to the adhesion of tablet cores to the tooling surfaces, while picking…

Blend Segregation during high-speed runs: GMP investigation steps and batch disposition

The first step in addressing blend segregation is recognizing the signals that suggest a problem may exist. Symptoms may manifest during the blending process or be detected during subsequent quality…

Tablet Lamination during tech transfer: sampling plan fixes to avoid repeat OOS

Recognizing the symptoms associated with tablet lamination is crucial for timely intervention. Symptoms may include:Click to read the full article.

Tablet Lamination during high-speed runs: GMP investigation steps and batch disposition

Symptoms of tablet lamination can manifest in various ways. Early detection is crucial to contain the issue before it escalates. Key observable signals include:Click to read the full article.

Blend Segregation during tech transfer: GMP investigation steps and batch disposition

Investigating Blend Segregation in the Tech Transfer Process: A Comprehensive Guide In pharmaceutical manufacturing, the transfer of technology from development to production is crucial yet fraught with challenges. One such…

Oot Dissolution Trend during FDA inspection readiness: GMP investigation steps and batch disposition

Identifying symptoms that suggest an Oot dissolution trend is the first step in the investigation process. These signals might manifest as unexpected results in dissolution tests that deviate from established…