Pharmaceutical Development: ICH Q8/Q(8)R
Pharmaceutical Development: ICH Q8/Q(8)R
Pharmaceutical Development: ICH Q8/Q(8)R
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Recent <strong>ICH</strong> & FDA Guidances<br />
Product<br />
Design<br />
Process<br />
Design<br />
Manufacturing<br />
Process<br />
Monitoring/<br />
Continuous<br />
Verification<br />
<strong>ICH</strong> <strong>Q8</strong>/<strong>Q8</strong>(R) - <strong>Pharmaceutical</strong> <strong>Development</strong><br />
FDA PAT Guidance<br />
<strong>ICH</strong> Q9 – Quality Risk Management<br />
<strong>ICH</strong> Q10 – <strong>Pharmaceutical</strong> Quality Systems<br />
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