Tài liệu GMP Nhật Bản

Submission Documents for Application of Drug Compliance Inspection (bản eng)

Tin tức liên quan

Consultation document on Annex 1 for Sterile medicinal products (bản eng)
Administrative Notice on Application of PICs GMP Guide (bản eng)
Administrative Notice on Application of PICs GMP Guide (bản eng)
GMP Compliance Inspection concerning Pharmaceuticals (including APIs) (bản eng)
GMP Ministerial Ordinance (Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs) (bản eng)
GQP Ministerial Ordinance (Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices) (bản eng)
Guidance on the Manufacture of Sterile Pharmaceutical Products (bản eng)
Guideline on Management of Computerized Systems (bản eng)
Regulations of Buildings and Facilities of Pharmacies, etc (bản eng)