SLIDE 1
G…(M)…P : Standard VS Barriers
การประชุมวิทยาการวัคซีนครั้งที่ 2 ระหวางวันที่ 15-17 มิถุนายน 2553 โรงแรมเรดิสัน พระราม 9 กรุงเทพมหานคร
G(M)P : Standard VS Barriers - - PowerPoint PPT Presentation
G(M)P : Standard VS Barriers - - PowerPoint PPT Presentation
G(M)P : Standard VS Barriers 2 15-17 2553
SLIDE 2
SLIDE 3
Materials System
Flow Chart of Raw Materials
Purchasing QA QC Warehouse
Production Plan Purchasing Storage Receipt Test Return
No No Yes Yes
Release Approval Reject Sampling Quarantine Area Request Test Visual Inspection
Overview การประชุมวิทยาการวัคซีนครั้งที่ 2 ระหวางวันที่ 15-17 มิถุนายน 2553 โรงแรมเรดิสัน พระราม 9 กรุงเทพมหานคร
SLIDE 4
Production System
Flow Chart of Production Production QA QC Planning Production B/R Issue Packaging Sampling Production Schedule Customer
In-Processing Check
Release Test
NCL Approval
Reject
No No Yes Yes
In house Approval
Storage
Lot Release
Overview
SLIDE 5
GMP Development Phase vs Faith
PHASE I
- ESTABLISHMENT Vision/Mission/Quality Policy
- STROMING - to put in place c GMP SYSTEM
PHASE II
- REVIEW & AUDIT - regularly
- CONTROL - to sustain system performance by good
Documentation and effective Training
PHASE III
- CONTINUE IMPROVEMENT to get a Better System (up to date )
SLIDE 6
Essential Elements for sustainable Achievement
KNOWLEDGE COMPETENCY AWARENESS ATTITUDE
ARE ADEQUATE……APPROPRIATE……SUITABLE FOR USE
SLIDE 7
How to make GMP Alive
Define
Define requirements
Set goal/vision
Clarify scope & target requirements of each system
Measure
Validate process/ strategy
Refine goal : short, medium and long term
Measure key steps by gathering data
Analyze
Develop causal hypothesis
Identify major possible root causes or burdens
Validate hypothesis
Improve
Develop ideas to remove root causes or burdens
Test solutions
Standardize solution
Document , Training and Implement new process, systems
Control
Establish standard measures to maintain performance
Documentation i.e. Quality Procedure ,SOP, record, report , specification etc.
Correct problems as needed
SLIDE 8
HOW to Keep on Improvement
Problem statement
Identify the problem(s) (be specific) – “Risk assessment”
Root causes
Identify the root causes
How to find out the root causes?
By observation? Tests? Interviews? Data vs. personal comment?
Solution
Identify the solution to fix the problem(s)
How? Have ideas or not? Brainstorming ideas?
Remove the root causes? How?
How to know the solution will work?
A solution may not be available at this moment.
Identify the direction or approach to deal with the problems
Action or Conclusion
What is next?
How to execute the ideas?
How to verify the effectiveness of the solution?
How to make the result be sustainable?
SLIDE 9
FACILITY & EQUIPMENT : GMP PHILOSOPHY
ADEQUATE……APPROPRIATE……SUITABLE FOR USE
SLIDE 10
BIOSAFETY LABORATORY
ADEQUATE……APPROPRIATE……SUITABLE FOR USE
SLIDE 11