Revalidation of Pharmaceutical Processes
Revalidation of Pharmaceutical Processes
Revalidation in pharmaceuticals refers to the documented evidence that an established process continues to operate in a state of control and consistently produces a product meeting predetermined specifications and quality attributes.
Types of Revalidation:
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Periodic Revalidation – Conducted at defined intervals (e.g., every 3–5 years) to ensure processes remain in control.
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Revalidation after Change – Required after any significant change (equipment, raw materials, formulation, process parameters, facility, utility systems, etc.) that could impact product quality.
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Revalidation after Failure/Deviation – Performed when a process shows abnormal trends, repeated deviations, or OOS/OOT results.
Key Aspects:
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Based on a comprehensive review of historical data, deviations, CAPA, complaints, and product quality trends.
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Ensures compliance with cGMP and regulatory expectations (FDA, EMA, WHO).
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Involves re-execution of process validation protocols (IQ, OQ, PQ) if necessary.
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Supports continuous process verification (CPV) under modern validation lifecycle approaches.
Benefits:
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Confirms product quality and patient safety.
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Demonstrates ongoing state of control.
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Meets regulatory compliance and audit readiness.
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