【求助】谁了解韩国的注册法规?12. Validation (This guideline is only for your reference) 12.1 Validation Policy 12.2 Validation Documentation 12.3 Qualification (DQ, IQ, OQ , PQ ) of critical equipments and ancillary systems ,Utility validation (UV) 12.4 Approaches to Process Validation (PV)– prospective validation 12.5 Process Validation Program (for only final or last crystallization stage in terms of purity and crystallization).12.6 Periodic Review of Validated Systems12.7 Cleaning Validation (CV)12.8 Validation of Analytical Methods (=Method Validation if it is global non-compendia) (MV) **** Computer System Validation (CSV), if used. If not used, just declare NOT Available.**** Process validation is for final crystallization process only. **** In case that specification complies with international compendia like EP. USP, BP, JP & DAB, validation only for residual solvents is required. ****Raw data is not required, and signed summary validation reports would be enough. ****PV is essential data (PV is a MUST) 这是韩国注册文件要求查看更多
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