Stopper coring after transport simulation – CAPA ineffectiveness
The signs of stopper coring typically manifest during routine quality control checks or post-transport simulation assessments. Key symptoms include:Click to read the full article.
Tips for Primary Packaging Defects
Glass vial crack during stability testing – packaging vs process investigation
Detection of glass vial cracks often arises from stability testing or during visual inspections. Key indicators to monitor include:Click to read the full article.
CCIT failure during packaging – regulatory risk assessment
The first step in addressing CCIT failures involves recognizing the symptoms or data signals indicative of a potential issue. Common indicators include:Click to read the full article.