Abstract: . . .  depending upon final Q10 document depending upon final Q10 document FDA FDA ICH Parties ICH Parties Q10 Q10 Regional Regional Implementation Implementation Q8, Q9, Q10 Q8, Q9, Q10 FDA FDA ICH ICH Parties Parties  . . .
. . .  Q8 and Q9 Consistent with regulations [21CFR 210 & 211] revision Consistent with regulations [21CFR 210 & 211] revision – – Modify/ replace FDA Quality System Guidance Modify/ replace FDA Quality System Guidance depending upon final Q10 document depending upon final Q10 document FDA FDA ICH Parties ICH Parties Q10 Q10 Regional Regional Implementation Implementation Q8, Q9, Q10 . . .
. . .  Q9 Consistent with regulations [21CFR 210 & 211] revision Consistent with regulations [21CFR 210 & 211] revision – – Modify/ replace FDA Quality System Guidance Modify/ replace FDA Quality System Guidance depending upon final Q10 document depending upon final Q10 document FDA FDA ICH Parties ICH Parties Q10 Q10 Regional Regional Implementation Implementation Q8, Q9, Q10 Q8, Q9, . . .
. . .  work together.” Lloyd Lloyd Dobens Dobens and Clare Crawford, and Clare Crawford, Thinking About Quality Thinking About Quality Page 9 The ICH Q8 “Desired State”: Connecting to Quality System (Q10) • • Product quality and Product quality and performance achieved and performance achieved and assured by design of assured by design of effective and efficient effective and efficient . . .
. . .  Guidance depending upon final Q10 document depending upon final Q10 document FDA FDA ICH Parties ICH Parties Q10 Q10 Regional Regional Implementation Implementation Q8, Q9, Q10 Q8, Q9, Q10 FDA FDA ICH ICH Parties Parties  . . .
--1889,5,189,1918,9444