3 - Mapping Challenges & Strategy to move Smartly (GMP & QMS) Lahore
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1st CCK Program at Lahore InshaAllah on 18 Feb 2018
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3 - Mapping Challenges & Strategy to move Smartly (GMP & QMS) Lahore
- 1. Mapping Challenges & Strategy to Move Smartly (Good Manufacturing Practices & Quality Management System) Obaid Ali, R. Ph., Ph. D. 18 Feb 2018 CCK - Lahore
- 2. Lack of experience in working in an internationally compliant environment Lack of experience facing inspectors of international world Passion and motivation is not enough protected
- 6. ProcessValidation Process control Understanding of Variability Use of statistical method
- 7. Design your process Build knowledge & understanding Development & Scale up experience Establish strategy for process control 1/3
- 8. Qualify your process Expect certainty on commercial manufacturing Extensive sampling, monitoring Sufficient statistical confidence 2/3
- 9. Continued Process Verification Assurance that process is in state of control Regularly collect & analyze product & process data Impact of variability & Knowledge Management 3/3
- 10. Product Lifecycle Development Technology Transfer Commercial Manufacturing Product discontinuation
- 11. Product Lifecycle (Process) F D A E M A Design Q8, Q11, Inspections Qualification Facility, Utility, Equipment Performance Qualification Contd. Verification GMP inspection, Q10, Quality Review Development Q8, Q11, Submission Qualification Traditional Cont. Verification Assessment in Inspection Contd. Verification GMP inspection, Q10, Quality Review
- 12. Science the only answer Integrity above all Culture of Quality
- 13. When life is everything Risk
- 14. P A R E N T E R A L S IV IM IG SC . . .
- 15. Tiny Living things Microorganisms that exist as single cells capable of growth, respiration, reproduction independent of other cells of the same or different kind.
- 17. G R O W T H
- 18. Cannot swim itself Cannot move itself Good Luck
- 19. Good Luck Sensitive to heat Sensitive to radiation Sensitive to chemicals
- 22. Volcanic Vents • High temperature Antarctica • Low temperature • Low nutrients Mount Everest • O2, low temperature, low nutrients Sahara Desert • low moisture, high temperature, low nutrients WFI Systems • Low nutrients Challenges (Extremes)
- 23. Dormant, tough, non-reproductive structure Forms in response to environmental stress Can survive for extended periods of time Produced by Gram Positive (+) Bacillus (rod) Challenges (Endospores)
- 26. From where vulnerability begins Nutrients Respiration Temperature Humidity pH Water also carry the microorganisms and supports growth too
- 27. Putting it all to use Cocci, Gram +ve Small/ medium colony White, beige to yellow Circular and convex Buttery Human Operation/ skin/ hands & hair Staphylococcus species 1
- 28. Putting it all to use Rods, Gram +ve Medium/ large colony Off white to beige Circular/ irregular and convex/ raised Mucoid, dry to grainy Environment such as soil (seasonal factor) Through shoe, air etc. Clostridium species 2
- 29. Putting it all to use Rods, Gram -ve Small to medium colony White, off white to beige Circular/ irregular and convex Mucoid to buttery Generally found in water (equipment piping ) Pseudomonas, E. coli species 3
- 30. Staphylococcus aureus • Aerobic • Gram +ve • Coccus Pseudomonas aeruginosa • Aerobic • Gram -ve • Rod Bacillus subtilis • Aerobic • Gram +ve • Rod • Spore forming Clostridium sporogenese • Anaerobic • Gram +ve • Rod • Spore forming Candida albicans • Yeast Aspergillus brasiliensis • Mold Compendial Organisms USP …ICH
- 31. Sterility Test-Growth Promotion (support the growth of wide range of organisms)
- 34. There were 55 recalls in the United States in 2014 due to foreign particles
- 35. Sources of Particulate Matter in Injectable Drug Products Environment Packaging materials Solution & formulation components Product- packaging interactions Process generated particles
- 36. Take an area as an example of challenge
- 37. 2m2 • Protects body from pathogens • Prevents loss of moisture • Body temperature regulation Diversity • Considerable diversity in species • Variation b/w different locations on body • Variation b/w individuals 30 million • Average person sheds 1 billion skin cells/ day • 10% have micro- organisms on them Human Skin Go in clean rooms They touch, shed, do things wrong sometimes
- 38. ORAL CAVITY High population High diversity SKIN Variable population Low diversity URETHRA/VAGINA High population Low diversity GUT High population High diversity People Ecology
- 39. Clinical Effects of Injected Particulate Matter Phlebitis Pulmonary emboli Pulmonary granulomas Immune system dysfunction Pulmonary dysfunction Infarction Death
- 40. Patient Population Patients with existing tissue damage e.g. trauma, surgery or sepsis Critically ill patients Neonates At highest risk
- 41. Sterility: complete absence of life or inability to reproduce • Cont’d In pharmaceutical industry ?
- 42. Sterility: More Complex & Technical • Cont’d Sterility: Expressed in Quantitative Terms
- 43. The probability definition for sterility derives from the fact that microbial death follows a geometric progression .i.e. the cells do not all die at once when exposed to lethal conditions • Cont’d The US-FDA defines sterilization as the “reduction of a microbial population to 10° (or one cell) plus an additional 6 log-cycles”
- 44. Sterility : Probability of a non-sterile unit in a lot or Sterility Assurance Level A product is considered sterile when the probability of a non-sterile unit is < 1 in 1, 000, 000 units; or a SAL of 10-6
- 45. Microorganisms die at a constant rate over a period of time For e.g. one million bacteria with a 90% death rate/ min 1st min 9 Lac dead/ 1 lac survivors 2nd min 90, 000 dead/ 10, 000 survivors Constant set of lethal conditions develop resistance 3rd min 9, 000 dead/ 1, 000 survivors 4th min 900 dead/ 100 survivors 5th min 90 dead/ 10 survivors 6th min 9 dead/ 1 survivor 7th min • ?
- 46. Particles Matter in oral dosage form too, See rational and discuss what would be the strategy? Type of Particle Size of Particle Shape of Particle Number of Particle
- 47. Infant Adult Particles Matter in oral dosage form too, See rational and discuss what would be the strategy?
- 48. Particles Matter in oral dosage form too, See rational and discuss what would be the strategy? Let’s Identify What can not be avoidable in GMP? Does it pose risk on patient safety?