Safeguarding public health. Deficiency Database Figures April June 2009

Transcription

1 Deficiency Database Figures April June 9

2 Relevant Inspections Performed = Number of Critical Observations = 1 Number of Major Observations = 191 Slide

3 Batch Release Complaint and Product Recall Sterility assurance Contamination, chemical/physical potential Finished product testing chemical Calibration of reference materials / reagentscleaning validation Quality Management Documentation manufacturing Supplier and contractor audit Quality management risk Production Planning and Scheduling Compliance with TSE guidelines management Investigation of anomalies CAPA Contamination, microbial potential Warehousing and distribution for activities Quality management change Line clearance, segregation and Starting material API control potential for mix-up compliance with GMP Documentation- quality systems Housekeeping cleanliness and Supplier and contractor technical elements tidiness agreements Investigation of anomalies Handling and control of packing Validation master plan and components documentation Self inspection Environmental monitoring Equipment Validation Quality management product Status labelling work in progress, Computerised Systems - quality review facilities, equipment documentation Personnel issues duties of key Sampling procedures and facilities Computerised systems personnel validation Personnel issues hygiene and Sampling procedures & facilities Process validation clothing retention & retain samples Personnel issues training Documentation specifications and Analytical Validation testing Design and maintenance of Starting material & packaging Cleaning validation premises component testing Design and maintenance of Computerised systems data Failure to respond to previous equipment manipulation findings Environmental control Finished product testing on-going Regulatory issues non stability compliance with MIA Calibration of measuring and test Intermediate and bulk product Regulatory issues noncompliance equipment testing MA/CTA In-process control and monitoring Finished product testing Regulatory issues Presentation title Deficiency of production Database operations April June 9 microbiological unauthorized activity Slide 3

4 Quality Systems - PSF, elements Slide Investigation of Anomalies Quality Management (QM) Quality Management 5 QM - Risk Management Self Inspection Batch Release QM - PQR Complaint & Product Recall CAPA Change Control

5 Personnel Training Hygiene & Clothing Key Duties Slide 5

6 Slide Calibration & Measuring & Test Equ Premises and Equipment Environmental Control Design & Maintenance of Equip Design & Maintenance of Facilities 1 1 1

7 Documentation manufac... Slide 7 Contamination, microbial pote Contamination, chemical/physic In-process control and monitorin Environmental monitoring Line clearance, segregati.. 1 Production planning and sched Status labeling work in progre Handling and control of packag Housekeeping cleanline.. Sterility assurance 1 1 Production

8 Documentation specifications Slide Finished product testing on-go Starting material and packaging Finished product testing - c... Quality Control 1 1 Calibration of reference materia Intermediate and bulk product te Sampling procedures and fac... Computerised systems data m Sampling procedures retentio Finished product testing - micro 1

9 Supplier and contractor te... Materials Management Slide 9 Starting material API co... Compliance with TSE gui... Warehousing and distributi.. Supplier and contractor audit 1 1

10 Process validation Slide 1 Equipment validation Computerised systems doc Validation master plan and do Computerised systems... Analytical Validation Cleaning validation Validation

11 Regulatory Compliance 3 5 Failure to respond to previous inspection findings 15 Regulatory issues unauthorized activity Regulatory issues non compliance with MIA Regulatory issues non-compliance with MA/CTA 1 5 Slide 11