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"Process Validation",

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Process Validation

According to the requirements of ICH-Q7, through the process validation, to prove the personnel, equipment, materials, methods, process and operation procedures and production environment are able to manufacture the products which can meet the intended purpose and registration requirements, the process is stable and reliable, and meet the GMP requirements.

Available relevant documents for process validation (bilingual version )

VMP for the project

Risk assessment of workshop introduces the production line

Equipment suitability assessment report

Analysis method validation report

Batch record template and corresponding procedures

Demo batch protocol & report

Process validation protocol

Process validation report

Stability study protocol