PIC/S GMP - PowerPoint PPT Presentation

About This Presentation
Title:

PIC/S GMP

Description:

Title: & Author: TR1B Last modified by: yatingyang Created Date: 9/7/2005 3:28:15 PM Document presentation format – PowerPoint PPT presentation

Number of Views:2800
Avg rating:3.0/5.0
Slides: 30
Provided by: TR1B
Category:
Tags: gmp | pic | efficacy

less

Transcript and Presenter's Notes

Title: PIC/S GMP


1
???????????????????
  • ???????
  • ?????????? ?????
  • ????????

2
??
  • ???????
  • ??????
  • 97.12.31????????
  • PIC/S GMP
  • DMF ??
  • SWOT?????????????????
  • ??

3
???????
  • 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

4
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
5
????????????
  • 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 ????
6
Fixed Controls State
Dynamic Controls State
7
(No Transcript)
8
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
9
Quality System Model --- FDA ?Guidance
for Industry Quality Systems Approach
to Pharmaceutical CGMP Regulations?, FDA,
2006.9
Management Responsibilities
Resources
Evaluation Activities
Manufacturing
10
An ICH vision The future Pharmaceutical Quality
Systems
Risk form Product / Process Development
11
??????
12
97.12.31????????
  • ??????,???????Pay for Value?,???????????????,?????
    ????????????

13
?????????????????
  • ???????????????????
  • ??PIC/S GMP
  • ??? DMF??

14
???????-????????
15
?????????????
???? ?? ???
?????? ??/???? ??(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)
15
16
???????
???????
???????
??GMP?? ????
??????
??????
???????
???????? /?????
???????
???? ????
??
????
??
??
16
17
????????? --- 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
18
????????????
?????????
??
????
?????????
??
??????
??
???????????
??????????
??
?????
????? ???????
??-?????????
???????? ???????
??
???????????
???????????
????
19
????????????
?????
?????
20
????????SWOT?????????
?? ??
?????PIC/S GMP?? ?????CTD?? 55?????????37??? 14????????47??? ????????(2300??) ?????????????, ?????? ???????????DMF?? ???????????????CTD??
?? ??
?????104?????GMP ????(??)??37???,?????????7??? ????????47???,?????????9??? ????900??????? ????2????????GMP?? ??????????CTD?DMF?? ???????2???????CTD?DMF?? ????10?????DMF??
21
??????
??????
???????
??
??
22
??????
?? 2 (7.1)
?? 2 (7.1)
??? 1 (3.6)
?? 15 (53.6)
?? 8 (28.6)
23
???????
  • ?????????

??
14???47?
24
???????
?? 3 (6.4)
?? 17 (36.2)
?? 14 (29.8)
??? 2 (4.3)
?? 11 (23.4)
47?
25
??
26
ICH Q8 Q9
????
????
????
CMC????
CMC????
CMC????
cGMP????
cGMP????
cGMP????
???????
???????
???????
Q10
??????
??????
??????
??
??
??
27
New GMP Initiative
How to do
What to do
Fixed controls state
Dynamic controls state
28
????
? ? ?
???? ????
???? ?????
?????? ????
  • ??

??
29
????
Write a Comment
User Comments (0)
About PowerShow.com