PIC/S GMP

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• 97.12.31????????
• PIC/S GMP
• DMF ??
• SWOT?????????????????
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• International Cooperation
• HarmonizationICH
• Strong Public Health Protection
• 21st century quality management
• ICH Q8-Pharmaceutical Development
• ICH Q9-Quality Risk Management
• ICH Q10-Pharmaceutical Quality System

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ICH Q8, Q9, Q10??
ICH Topic Status
Q8 Pharmaceutical Development Step 5, 2005.Nov
Q9 Quality Risk Management Step 5, 2005.Nov
Q10 Pharmaceutical Quality System Step5, 2008.Jun
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• Science-based
• Based Manufacturing program
• Role of PAT
• Design space
• DOE
• Risk-based
• Clear understanding
• FMEA and HACCP
• as it related to process
• System-based
• Quality systems throughout the product Lifecycle

Q8Pharmaceutical Development ??????
Q9Quality Risk Management ??????
Q10 Pharmaceutical Quality System ????
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Fixed Controls State
Dynamic Controls State
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(No Transcript)
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Pharmaceuticals Risk Management
Pre-Approval Post-Approval

Industry
Clinical view
RD
Preclinical
PhaseI, II, II
Pharmaco-vigilance
Risk-Benefit Assessment
GMP view
Design


StabilityContinuous Improvement
Production Development Scale-up, Validation
cGMP (Regulatory Requirements)
Regulator
Submission/ReviewProcess Pre-approval Inspection
Inspection
ApprovalDecision
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Quality System Model --- FDA ?Guidance
for Industry Quality Systems Approach
to Pharmaceutical CGMP Regulations?, FDA,
2006.9
Management Responsibilities
Resources
Evaluation Activities
Manufacturing
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An ICH vision The future Pharmaceutical Quality
Systems
Risk form Product / Process Development
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97.12.31????????

• ??????,???????Pay for Value?,???????????????,?????
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• ??PIC/S GMP
• ??? DMF??

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?????? ??/???? ??(PK/PD/BA/BE) ???? ?????????????????????? ????????(bioequivalence, BE) ??????????
?? ??????(Chemistry, Manufacturing and Controls, CMC) GLP, GCP, cGMP ??????(Chemistry, Manufacturing and Controls, CMC) GLP, GCP, cGMP
?? Primary packing material Primary packing material
?? Labeling(direction of use) Labeling(direction of use)
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????????? --- Scope of CTD
Common Technical Document (CTD)Implementation
Coordination Group
organized by Implementation Coordination Group
Members plus members in CTD-Q, CTD-S, CTD-E eCTD
presentingJune 13 02 General Information on the
CTD
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????????SWOT?????????
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?????PIC/S GMP?? ?????CTD?? 55?????????37??? 14????????47??? ????????(2300??) ?????????????, ?????? ???????????DMF?? ???????????????CTD??
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?????104?????GMP ????(??)??37???,?????????7??? ????????47???,?????????9??? ????900??????? ????2????????GMP?? ??????????CTD?DMF?? ???????2???????CTD?DMF?? ????10?????DMF??
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?? 2 (7.1)
?? 2 (7.1)
??? 1 (3.6)
?? 15 (53.6)
?? 8 (28.6)
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14???47?
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?? 3 (6.4)
?? 17 (36.2)
?? 14 (29.8)
??? 2 (4.3)
?? 11 (23.4)
47?
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ICH Q8 Q9
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CMC????
CMC????
CMC????
cGMP????
cGMP????
cGMP????
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Q10
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New GMP Initiative
How to do
What to do
Fixed controls state
Dynamic controls state
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