Unique Skill ID: ES1F75A8497E931A579E

Process Validation

Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification.

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Biocompatibility
Contract Manufacturing
Corrective And Preventive Action (CAPA)
ISO 13485 Standard
Medical Device Directive
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Product And Manufacturing Information
Qualification Protocols (IQ/OQ/PQ)
Test Method
Validation Protocols

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