3 - GMP June 2022 - CQS.pdf
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Session organized by Centre for Quality Sciences on 12 June 2022 at Hotel Marriott, Karachi
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3 - GMP June 2022 - CQS.pdf
- 1. GMP & Limitations Understand Thin Ice
- 5. How Much GMP Zero Consistency Issue Zero Contamination Issue Less than Zero Mix-Up Issue
- 10. Can we make tea of same taste every time and maintain its taste for every sip in each shape of cup with different tea making process with different source of inputs? Lets understand … we can give output from input but it will not guarantee desired outcome in every situation
- 13. Pharmaceutical quality is MULTI-VARIATE and our approach to quality is uni-variate … one test at a time
- 14. Pharmaceutical quality is MULTI-VARIATE and our approach to quality is uni-variate … one test at a time
- 15. We don’t look into interactions and interrelationships between the attributes and methods we use Pharmaceutical quality is MULTI-VARIATE and our approach to quality is uni-variate … one test at a time
- 18. Epileptic fit due to low dosing Consistency issue
- 19. Minimum Effective Concentration Elimination pattern
- 22. Steady state level Concentration Pharmacological response altered
- 23. Physical attributes of product How much are they important?
- 25. Let’s challenge Where content is critical Which one in factory Which one in home Dosage Uniformity to Content Uniformity Understand the criticality Take 1 TSF - PO 250 mg/5 ml solution Take 1 - PO 250 mg/tab
- 26. Let’s challenge Where content is critical Which one in factory Which one in home Take 1 TSF - PO 250 mg/5 ml solution Take 1 - PO 250 mg/tab Dosage Uniformity to Content Uniformity Understand the criticality
- 27. Let’s challenge Where content is critical Which one in factory Which one in home Take 1 TSF - PO 250 mg/5 ml solution Take 1 - PO 250 mg/tab Dosage Uniformity to Content Uniformity Understand the criticality
- 29. Narrow & Wide Therapeutic Value Content Dose LD50 & ED50 Ciprofloxacin 250 mg TABLET 250 mg Anti-infective Wide Index
- 30. Narrow & Wide Therapeutic Value Content Dose LD50 & ED50 Thyroxin 250 mcg TABLET 250 mcg Anti-thyroid Narrow Index Consistency
- 32. LD – 50 50 --- Sugar Or Salt ---
- 33. ED – 50 50 --- Sugar Or Salt ---
- 34. 4 mg is lethal 3 mg is effective 4 mg is lethal 1 mg is effective
- 39. Defensive mechanism IgE Histidine release & Histamine shock Sometimes life threatening
- 40. Contamination & Cross- contamination What is Unwanted
- 43. Group Cleaning of utensils used in different products may increase risk of contamination
- 44. Risk
- 45. Group Cleaning of utensils used in different products may increase risk of contamination Remember final rinsing is done individually one by one
- 46. Contamination & Cross-contamination occurs in pharmaceutical manufacturing process How
- 47. Contamination & Cross-contamination occurs in pharmaceutical manufacturing process How P A E Flow Cleaning Maintenance M
- 48. Drug Product DS Excipients Equipment Utilities Container Closure Footprints of knowledge is in your backyard to navigate you …
- 49. Drug Substance Inorganic reagents Organic material Processing aids Equipment Metal catalysts Water & Solvents Container Closure Footprints of knowledge is in your backyard to navigate you …
- 50. Excipients 1. Mind (Talc) 2. Metal catalysts (Mannitol) 3. Plant origin (cellulose) 4. Animal origin (lactulose) 5. Without metal catalysts (colloidal SiO2) Footprints of knowledge is in your backyard to navigate you …
- 53. Dedicated
- 58. If we are manufacturing hhxxxxxxxxxxx Product Same
- 59. Why do we need to clean between 2 batches If we are manufacturing xxxxxxxxxxxxxxxx Product Same If we are manufacturing hhxxxxxxxxxxx Product Same
- 60. Why do we need to clean between 2 batches ? If we are manufacturing hhxxxxxxxxxxx Product Same
- 61. 1 Preservance of purity & Reduction of Uncertainty
- 62. 1 2 Preservance of purity & Reduction of Uncertainty Control of Process & Control of Impurities
- 63. 1 2 3 Preservance of purity & Reduction of Uncertainty Control of Process & Control of Impurities Isolation & Traceability of manufacturing process
- 64. Risk two batches of same product Ciprofloxacin & Ciprofloxacin
- 65. two batches of different product of same therapeutic class two batches of same product Ciprofloxacin & Ofloxacin Risk
- 66. Risk two batches of different product of different therapeutic class two batches of different product of same therapeutic class two batches of same product Risperidone & Glimipride
- 67. What GMP Mix-Up
- 68. Pyrimethamine instead of Starch in Isosorbide 5 MN tablet Mix up Inventory Ignorance Reporting Deaths
- 69. Loratadine in Losartan Mix up Inventory Omission Poor Control ?????
- 70. GMP Error Mix Up
- 71. GMP Error Mix Up
- 72. GMP Error Mix Up
- 73. Quality
- 76. Quality By Compliance By Culture From where error comes in?
- 77. Quality By Compliance By Culture From where error comes in? There was a line clearance
- 78. Quality By Compliance By Culture From where error comes in? There was a line clearance Is it not true?
- 79. Quality By Compliance By Culture From where error comes in? There was a line clearance? Is it not true? Errors have multiple reasons for their birth ?
- 80. Bad Judgment
- 84. Poor control on un-used labels
- 85. Poor control on rejections stay, storage & destruction
- 86. Poor control during dispensing & re-packaging
- 87. Simultaneous handling of multiple materials
- 88. Poor control on location of different materials that look similar
- 89. One printer for multiple computers working simultaneously
- 90. Materials packaging having same color or combination of colors or dress
- 91. One facility for multiple products with poor physical controls & clearance oversight
- 92. Placement of different in- process materials in one room, e.g. sterile and non-sterile
- 93. Mix up can occur Mfg Mfg Mfg Lines Process Goods L P G