Cleaning Validation: tutti i riferimenti

 Per chi deve redigere un protocollo di Cleaning Validation o per chi vuole aggiornare quello già in essere, ecco di seguito tutti i riferimenti utili a siti ufficiali, articoli, ecc. riguardanti questo argomento:

• EMA: 
• Guideline on setting health based exposure limits for usein risk identification in the manufacture of different medicinal producs in shared facilities
• Questions & Answers
• FDA: 
• Guidance for IndustryProcess Validation: GeneralPrinciples and Practices
• Questions & Answers
• Validation of Cleaning Processes
• WHO
• Annex 2: Points to consider when including Health-Based ExposureLimits (HBELs) in cleaning validation
• Annex 3: Good manufacturing practices:guidelines on validation

• APIC:
• GUIDANCE ON ASPECTS OF CLEANING VALIDATIONIN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS