Difference between Process Validation and Product Validation
| Aspect | Process Validation | Product Validation |
|---|---|---|
| Definition | Documented evidence that a manufacturing process, operated within established parameters, can consistently produce a product meeting its predetermined quality attributes. | Documented evidence that a specific product meets all its intended use requirements, specifications, and regulatory standards. |
| Focus | The process and its ability to consistently deliver quality. | The final product and its compliance with quality, safety, and performance requirements. |
| Objective | To ensure the process is capable, reproducible, and reliable before commercial production. | To ensure the product is safe, effective, and compliant before release to the market. |
| Scope | Covers equipment, methods, environmental conditions, process parameters, and in-process controls. | Covers product specifications, quality attributes, stability, packaging, and performance testing. |
| When Conducted | During product development, scale-up, and before routine manufacturing (also during major process changes). | During product development and before product release for distribution (also when significant changes occur). |
| Examples | – Validating tablet compression process parameters. – Validating sterilization cycles for injectables. | – Validating that a paracetamol tablet meets dissolution, assay, and stability requirements. – Validating vaccine potency and sterility. |
| Regulatory Basis | ICH Q8/Q9/Q10, US FDA Process Validation Guidance, WHO GMP, EMA guidelines. | ICH Q6A/Q6B, pharmacopeial monographs (USP, EP, JP), product-specific regulatory requirements. |
| Outcome | A validated process capable of consistent production. | A validated product meeting specifications for safety, efficacy, and quality. |
Key Points
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Process Validation focuses on how you make it.
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Product Validation focuses on what you made.
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Both are required for GMP compliance in pharmaceuticals.
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Process validation is usually prerequisite to product validation.
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