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API Process Validation: How to reduce validation costs (wow)
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The FDA process validation guidance speaks to phase 1 being process design. When your drug substance process is designed is very robust, what does process validation entail? Non-critical synthesis steps are not required to be validated according to ICH Q7.
For API’s, the Pharmaceutical Quality Risk Management has a huge impact on process validation. Process validation is only one-way Quality Risk Management in the pharmaceutical industry is changing the compliance landscape.
The approach involves ensuring variation impacting Critical Quality Attributes is controlled. The validation covers all Critical Process Parameters identified in the Quality by Design process.
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For API’s, the Pharmaceutical Quality Risk Management has a huge impact on process validation. Process validation is only one-way Quality Risk Management in the pharmaceutical industry is changing the compliance landscape.
The approach involves ensuring variation impacting Critical Quality Attributes is controlled. The validation covers all Critical Process Parameters identified in the Quality by Design process.
Follow our LinkedIn Business Page to ensure you see all of our valuable content.
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