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Tips for Primary Packaging Defects

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  • Manufacturing Defects & Product Failures
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Stopper coring during stability testing – regulatory risk assessment

The first step in investigating stopper coring during stability testing involves recognizing the symptoms that indicate a potential issue. Symptoms can manifest both visually and through analytical results. Common indicators…

Stopper coring during inspection – CAPA ineffectiveness

The first signals of stopper coring typically manifest during visual inspections, often through the observation of debris or particulate matter present in vials or ampoules. These symptoms can include:Click to…

Glass vial crack after transport simulation – CAPA ineffectiveness

Identifying symptoms is critical in any deviation investigation. When glass vials show signs of cracking after a transport simulation, various observations may be noted on the manufacturing floor or in…

Blister seal failure after supplier change – CAPA ineffectiveness

Identifying the symptoms indicating a potential blister seal failure is the first step in managing this manufacturing defect. Common signals may include:Click to read the full article.

Glass vial crack during packaging – CAPA ineffectiveness

Identifying the symptoms associated with cracks in glass vials is the first step in addressing this manufacturing defect. Common symptoms include:Click to read the full article.

Blister seal failure after transport simulation – packaging vs process investigation

Identifying symptoms or signals that indicate a blister seal failure is the first step in initiating an investigation. Common symptoms include:Click to read the full article.

Container closure mismatch during packaging – regulatory risk assessment

Identifying symptoms indicative of a container closure mismatch during packaging is pivotal for initiating corrective actions timely. The following symptoms may arise during production:Click to read the full article.

Stopper coring after supplier change – CAPA ineffectiveness

Symptoms of stopper coring typically manifest in the manufacturing or laboratory environments as follows:Click to read the full article.

Stopper coring during stability testing – packaging vs process investigation

Stopper coring is marked by the dislodgment of rubber particles from the surface of the stopper during the withdrawal of a syringe or other sampling device. This phenomenon can lead…

CCIT failure during packaging – packaging vs process investigation

The initial signs of CCIT failure can manifest in various forms that should alert manufacturing and quality control teams. Symptoms may include:Click to read the full article.

Blister seal failure during inspection – packaging vs process investigation

Identifying the initial signs of blister seal failure is crucial for timely intervention. Common symptoms may include:Click to read the full article.

Glass vial crack after transport simulation – regulatory risk assessment

Identifying the first signs of potential manufacturing defects is critical to mitigate risks effectively. Signs of glass vial cracks may vary in visibility and can include:Click to read the full…

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Quick Guide

  • Dosage Forms & Drug Delivery Systems
    • Solid Oral Dosage Forms (Tablets, Capsules)
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