Compression Defects and Corrective Actions : Pharmaceutical Guidelines

Compression Defects and Corrective Actions

Most of the defects in tablets occur in compression stage of tablets and these could be categorized as critical, major and minor defects on the basis of the severity of the defect.
1. All defects have observed during an inspection of compression machine will be classified with the following category:
Critical: Those defects have a high probability of adverse impact on the effectiveness of the product or to the consumer. The example includes the wrong product in the container, the incorrect label on the container, and contaminated tablet by grease, oil.

Major: Those defects with the low probability of adverse impact on the effectiveness of the product or to the consumer. The example includes a broken tablet (more than 3% by visual checking), hardness, weight variation than defined acceptance criteria, failure in disintegration time, a large number of black particles, and failure in the set parameter of thickness.

Miner: Those defects unlikely to have any adverse impact on the effectiveness of the product or to the consumer. Example include miner chipped/capped/broken tablets, miner black particles, excessive dust particles of the same product.

2. The above mention observation category and their classification not limited to defined examples, after finding observation Q A personnel will asses the impact of the defect on the effectiveness of the product and take corrective action accordingly.

3. In case any defect is Critical IPQA personnel will inform immediately Production Manager/Officer and stop the compression procedure immediately. Record the observations in the Packaging Line. Segregate the compressed materials and rectify the problem to continue batch for compression.

4. If the problem is reoccurred further packing will stop and cause of the problem will be identified and corrective action will be taken.

5. In case any defect is Major IPQA personnel will inform immediately Production Manager/Officer and stop the compression procedure immediately. Record the observations in the compression. Segregate the compression goods and rectify the problem to continue batch for compression machine.

6. If the problem is reoccurred further packing will stop and cause of the problem will be identified and corrective action will be taken by following the step.

7. In case any defect is Miner IPQA personnel will inform immediately Production Manager/Officer. Record the observations in the compression record of BMR.

8. Increase the inspection scope in compressed material take the sample from the different bucket and different locations.
Related: Different Tablet Defects

9. If the problem is reoccurred further compression will stop and cause of the problem will be identified and corrective action will be taken accordingly.

10. A limit for miner observations is 3 % (whenever applicable) in final compressed goods.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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