Download tài liệu GMP PIC/S

Download tài liệu GMP PIC/S

          Tên tài liệu                                         Loại file
         PIC/S GMP Basic Requirements for APIs   PDF
        Basic Requirements for Medicinal Products   PDF
        Guidelines to GDP for medicinal products   PDF
        PIC/S GMP Guidance Annexes   PDF
        PIC/S GMP Guide Introduction   PDF
        Guidance on classification of GMP deficiencies   PDF
        Guidance on GMP inspection reliance   PDF
        Guidance on parametric release   PDF
        Guide for blood establishments   PDF
        Guidelines on excipient GMP risk assessment   PDF
        GMP Guidelines on exposure limits   PDF
        Guidelines on GDP of active substances for human use   PDF
        Consultation document on Annex 1 for Sterile medicinal products   PDF
        Guidelines to inspections of source plasma establishments and plasma warehouses   PDF
        Guidlines for computerised systems in regulated GXP environments   PDF
        Guidlines for the preparation of medicinal products in healthcare establishments   PDF
        Isolators used for aseptic processing, sterility testing   PDF
        Validation of Aseptic processes   PDF
        Recommendation on risk-based inspection planning   PDF
        Recommendation on sterility testing   PDF
        Technical interpretation of revised Annex 1 to PICS GMP   PDF