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Https://www.ema.euro Pa.eu/en/documents/o Ther/questions-answe Rs-implementation-ri Sk-based-prevention- Cross-contamination- Producti.pdf

questions-answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf
Preview of https://www.ema.euro pa.eu/en/documents/o ther/questions-answe rs-implementation-ri sk-based-prevention- cross-contamination- producti
🔗 Source: ema.europa.eu
📊 Size: 147 KB
👤 Author: European Medicines Agency
⬇️ Downloads: 82

Summary

The European Medicines Agency (EMA) provides guidance on implementing risk-based prevention of cross-contamination in production. Key points include:
- Health-Based Exposure Limits (HBELs) should be established for all medicinal products, with periodic reassessment throughout a product's lifecycle.
- A framework for defining the significance of HBELs can be used to determine the extent of Quality Risk Management (QRM) and control measures required.
- Manufacturers should use HBELs to determine controls and assess existing measures via a QRM process, considering the risks of cross-contamination and the potential harm to patients/animals.
- Competencies required for developing HBELs include expertise in toxicology/pharmacology and experience in determining health-based exposure limits.
- Contract givers are responsible for providing HBEL assessments or data to contract manufacturers, and manufacturers should retain historical cleaning limits as alert limits.
- Analytical testing is expected at each changeover unless justified otherwise via a robust QRM process, and visual inspection should be used to determine cleanliness of equipment, with established thresholds for residue visibility.

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Description

The European Medicines Agency (EMA) provides guidance on implementing risk-based prevention of cross-contamination in production.

Technical Information

  • File Format: PDF
  • File Size: 147 KB
  • Pages: 4
  • Language: EN
  • Author: European Medicines Agency
  • Total Downloads: 82
  • Last Updated: 3 hours ago

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