GMP审计的准备.pdfVIP

White Paper Preparing for GMP audits GMP GMP- GMP GMPFDA © 2010 PharmOut Pty Ltd Page 1 of 10 Version - 0 1 White Paper Preparing for GMP audits TGAGMP - QMS 3 TGA 20 TGA TGA GMP TGA © 2010 PharmOut Pty Ltd Page 2 of 10 Version - 0 1 White Paper Preparing for GMP audits A1 A2 A3 24 18 12 30 20 12 36 24 12 A1 = 10 A2 = 1-5 11 A3 = 5 15 = 15 TGA 2 TGA .au/docs/html/auditmed.htm .au/docs/html/gmpcodes.htm .au/docs/html/gmpcodqa.htm OOS © 2010 PharmOut Pty Ltd Page 3 of 10 Version - 0 1 White Paper Preparing for GMP audits TGA 2010 7 1 APRTGA APRTGA / SMF VMP SMF SMF .au/docs/html/siteinfo.htm © 2010 PharmOut Pty Ltd