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巴西Anvisa的GMP guidline和审计指南供大家参考 a) Annex “RDC 69.14” : it is a GMP guidance that ANVISA will be used to carry out the inspection. b) Annex “POP O SNVS 014”: it is a ANVISA SOP which is used by ANVISA to Categorization of non-compliances, grading of the establishment regarding the compliance with good practices and determination of regulatory risk. c) ANVISA Inspection Agenda Model: this document is a “standard audit agenda” which is normally covered by ANVISA during an inspection week. This is not an official agenda but you take in mind the main points that are checked regarding the facilities, warehouse, QA, QC and so on. |