Common Defects and Troubleshooting in Manufacturing
Start with the big picture
Defects may appear as tablet issues such as capping, weight variation, sticking, or inconsistent color, as well as packaging problems such as poor seals, mislabeling, or leaks. The lesson also considers defects in liquid dosage forms and examples involving tablet weight variation, suspension precipitation, and blister-seal failure. Troubleshooting uses evidence to investigate potential causes; tools include fishbone diagrams, the 5 Whys, FMEA, and batch-record review. CAPA distinguishes actions that correct a current issue from actions intended to prevent it from happening again. Root-cause investigation should use data and cross-functional input, while CAPA actions need documented effectiveness checks. Strong prevention practices help limit repeated failures and associated risks.
What you'll learn
- Recognize common defects in tablets, capsules, liquid dosage forms, and packaging.
- Explain how manufacturing defects can affect product quality, safety, and compliance.
- Identify troubleshooting tools used to investigate potential root causes.
- Distinguish corrective actions from preventive actions within CAPA.
- Describe why CAPA effectiveness verification and documentation matter.
Continue your study
Work through the complete notes and reinforce the topic with the study tools available in the full lesson.
