G(M)P : Standard VS Barriers - PowerPoint PPT Presentation

G…(M)…P : Standard VS Barriers การประชุมวิทยาการวัคซีนครั้งที่ 2 ระหวางวันที่ 15-17 มิถุนายน 2553 โรงแรมเรดิสัน พระราม 9 กรุงเทพมหานคร

CONTENT of GMP SYSTEM  Quality system  Facility and Equipment System  Materials System  Production System  Laboratory System  Packaging and Labeling System  Logistics

Materials System Overview Flow Chart of Raw Materials Purchasing Warehouse QA QC Production Plan Purchasing Receipt No Visual Return Inspection Yes Quarantine Area Request Test Sampling Yes Release Approval Test No Reject Storage การประชุมวิทยาการวัคซีนครั้งที่ 2 ระหวางวันที่ 15-17 มิถุนายน 2553 โรงแรมเรดิสัน พระราม 9 กรุงเทพมหานคร

Production System Overview Flow Chart of Production Production QA QC Planning Production B/R Issue Production Schedule No In-Processing Check No Yes Release Sampling Test Reject Yes Packaging In house Approval Lot Release Storage NCL Approval Customer

GMP Development Phase vs Faith • ESTABLISHMENT Vision/Mission/Quality Policy • STROMING - to put in place c GMP SYSTEM PHASE I • REVIEW & AUDIT - regularly • CONTROL - to sustain system performance by good PHASE II Documentation and effective Training • CONTINUE IMPROVEMENT to get a Better System (up to date ) PHASE III

Essential Elements for sustainable Achievement KNOWLEDGE COMPETENCY ARE AWARENESS ATTITUDE ADEQUATE……APPROPRIATE……SUITABLE FOR USE

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

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? 

FACILITY & EQUIPMENT : GMP PHILOSOPHY ADEQUATE……APPROPRIATE……SUITABLE FOR USE

BIOSAFETY LABORATORY ADEQUATE……APPROPRIATE……SUITABLE FOR USE