Dosage Forms & Drug Delivery Systems – Page 12

Assay Oos after temperature excursion: how QA should write CAPA for inspectors

A temperature excursion often manifests through variations in assay results, but the initial symptoms may not always be obvious. During routine inspections or batch testing, specific indicators can reveal potential…

Emulsion Inversion after excipient change: mixing and sampling controls for QA review

Detecting emulsion inversion often begins with visual or instrumental signals observed during the production process, stability testing, or post-manufacturing evaluations.Click to read the full article.

Phase Separation after temperature excursion: water system and sanitation checks

Identifying phase separation early is crucial for preventing greater issues down the line. Common symptoms that signal a problem include:Click to read the full article.

Foaming And Air Entrapment after temperature excursion: water system and sanitation checks

Investigating Foaming and Air Entrapment Issues Following Temperature Excursion in Pharmaceutical Water Systems Temperature excursions in pharmaceutical manufacturing can lead to significant process deviations, particularly in liquid oral dosage forms…

Color Change in cream manufacturing: GMP investigation and CAPA strategy

Recognizing the initial symptoms or signals of a color change during cream manufacturing is the first step in addressing potential quality issues. Symptoms can vary from batch to batch, but…

Hold Time Bioburden Rise during EU/UK market supply: mixing, sampling, and hold-time controls

Identifying potential issues early is essential in pharmaceutical manufacturing. The initial symptoms of rising bioburden during hold time may not always be immediately evident. However, several signals should prompt an…

Crystallization In Syrup during bulk hold: how QA should write CAPA for inspectors

Recognizing the signs of crystallization in syrup during bulk hold is critical for swift intervention. Key symptoms may include:Click to read the full article.

Texture Variability in ointment filling: mixing and sampling controls for QA review

Identifying texture variability begins with observing specific symptoms in the production environment. Symptoms may manifest in various ways:Click to read the full article.

Bioburden Spike Pre-Filtration during hold-time study: CAPA package with evidence and effectiveness checks

Symptoms of potential bioburden spikes may manifest as elevated levels of microbial contamination observed during routine quality control checks or during hold-time studies. Signals that should prompt immediate attention include:Click…

Sterility Test Failure during aseptic filling: data integrity checks for lab and shop floor

Before diving into root causes of sterility test failures, it's important to recognize the various signals that can indicate a potential issue:Click to read the full article.

Air Entrapment during inspection preparation: GMP investigation and CAPA strategy

In a manufacturing environment, recognizing the symptoms and signals of air entrapment is critical for prompt intervention. Some of the most common signals include:Click to read the full article.

Unplanned Line Stoppage post-sterile filtration: facility, people, process root cause mapping

The first step in addressing an unplanned line stoppage is to identify symptoms or signals that can indicate underlying issues. Examples may include:Click to read the full article.