ธีรนารถ Jan Experiences in GMP Inspection in WHO Vaccine Prequalification Scheme ธีรนารถ จิวะไพศาลพงศ์ กองชีววัตถุ กรมวิทยาศาสตร์การแพทย์ GMP course 2549

ธีรนารถ Jan WHO Vaccine Quality Assurance Scheme Vaccine Prequalification (priorities, EPI vaccines) NRA Assessment Manufacturer site visit

ธีรนารถ Jan National Regulatory Authority Functions A A published set of requirements for licensing S Surveillance of vaccine field performance S System of lot release U Use of laboratory when needed R Regular inspections for GMP E Evaluation of clinical performance System to regulate vaccine

ธีรนารถ Jan Control system assessment Licensing & GMP Inspection Transparency, one standard, human resource (competency & adequate), QA system, enforcement Lot release For both local and imported products, protocol review, human resource Lab access Independent lab. (NCL), Lab. Quality system, human resources, trend analysis, involvement in GMP inspection

ธีรนารถ Jan Control system assessment Clinical trial evaluation Trials controlled by NRA compliance with GCP, GMP, GLP Post marketing surveillance Guidelines, systems at national and sub-national levels, safety evaluation, participation/linkage among responsible organization (NRA, NCL, EPI)

ธีรนารถ Jan Site visit for vaccine prequalification GMP inspection  Production  Quality Control QA system assessment  Management system  Production  Quality Control  Marketing Product distribution Complaint/ Feed back from customer

ธีรนารถ Jan เอกสารที่ส่งมาให้ ตรวจสอบก่อน site visit

ธีรนารถ Jan Organization -Scope of work -Organogram QC and QA independent from production -Key personnel : Name and education background -Number of staff and education background in each unit

ธีรนารถ Jan Facilities Plant layout (Production & QC areas)  Work flow  Materials flow infectious & non infectious  Personal flow  Clean room classification  Pressure differences in each area + Air flow  Water flow

ธีรนารถ Jan System & Performances QA system Production process and control conditions QC testing & specifications Shelf life of intermediate products & finished products (where appropriate)

ธีรนารถ Jan Site visit

ธีรนารถ Jan GMP Inspection FacilitiesInvestigation Practices Documentation review and personnel interview  SOPs  Validation data (sampling)  Equipment calibration/validation data (sampling)  Stability data  Batch records (sampling)  QC testing results (sampling)  Training records (sampling)  Trend analysis  อื่นๆที่เกี่ยวกับ QA system

ธีรนารถ Jan Key elements in GMP inspection Documentation evidences (SOPs, records, reports) Consistency  Change control  Trend analysis Reasonable flexibility  Poor facility may be improved by good practice  Good facility without good practice can’t fulfill GMP requirements

ธีรนารถ Jan