Emerging Trends & Developments, Common Inspection Deficiencies and Other Concerns Jenny Hantzinikolas Director, Inspections Section , Manufacturing Quality Branch Medical Devices and Product Quality Division, TGA GMP Forum 26 June 2018
Overview • Inspection outcomes • Inspections conducted and timeframe • Inspection types inspected • Common deficiencies
What does the data tell us? 3
Domestic Inspection Outcomes (Medicines and Blood, Tissue and Cellular Therapies) 4
Domestic Inspections Conducted within Time Period (Medicines and Blood, Tissue and Cellular Therapies) 5
Overseas Inspection Outcomes (Medicines and Blood, Tissue and Cellular Therapies) 6
Overseas Inspections Conducted within Time Period (Medicines and Blood, Tissue and Cellular Therapies) 7
Inspection trends 8
Inspection trends Medicines – domestic breakdown according to manufacturing type
Inspection trends Medicines – overseas breakdown according to manufacturing type
Common deficiencies types 11
Common deficiencies for non sterile medicines manufacturers 2017 – Domestic and overseas manufacturers Poor investigations Not following procedures Marketing authorisation Cleaning Potential for cross contamination Quality control Change control Computerised systems Poor procedures/documentation training
Common deficiencies for sterile medicines manufacturers 2017 – Domestic and overseas manufacturers Poor investigations Quality control Training Sterility assurance Potential for cross contamination Stability Change control premises validation Risk of particulate and /or microbial contamination
Common deficiencies for all API manufacturers 2017 – Domestic and overseas manufacturers Quality management Laboratory controls Training Specifications Computerised systems References standards Batch production records Validation In process controls Rejection and reuse of materials
Common deficiencies for complementary medicines manufacturers 2017 – Domestic and overseas manufacturers Poor investigations Computerised systems Marketing authorisation Training Potential for cross contamination Cleaning Procedures/Documentation Facility Validation Starting materials
Common deficiencies for sunscreens manufacturers 2017– Domestic and overseas manufacturers Poor investigations Quality risk management Cleaning Potential for cross contamination Computerised systems Change control
Common deficiencies for gas manufacturers 2017– Domestic manufacturers Procedures/documentation Testing Computerised systems Specifications
Common deficiencies for compounding manufacturers 2017 – domestic manufacturers Poor investigations Cleaning Transfer of materials Validation Stability
Common deficiencies for radiopharmaceutical manufacturers 2017 – domestic manufacturers Poor investigations Testing Training Transfer of materials Validation Microbial contamination
Common deficiencies Data Integrity deficiencies were incorporated into the areas of q Documentation q Automated systems q Quality control ( question from conference)
Questions 21
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