Pharmaceutical Manufacturing Operations
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Pharmaceutical Manufacturing Operations
- 1. Pharmaceutical Manufacturing Operations Science behind Drug Quality (A talk with final year Pharmacy students) Obaid Ali & Roohi B. Obaid 24 Mar 2019
- 2. Current Judgment No obligations From experience & References Personal Point of View DISCLAIMER
- 3. Pharmacy Students Lets recheck the alignment to keep journey on progressive mode
- 4. What do you know? 1
- 5. What you don’t know? What do you know? 1 2
- 6. What you don’t know? What you should know? What do you know? 1 2 3
- 7. Are you different from other disciplines? 1
- 8. Does this difference has significant impact? Are you different from other disciplines? 2 1
- 9. Does this difference has significant impact? How much it is flexible to excellence? Are you different from other disciplines? 2 1 3
- 10. What do you know?
- 11. Theory
- 12. Theory How drugs are manufactured
- 13. Theory How drugs are manufactured How drugs are tested
- 14. Theory How drugs are manufactured How drugs are tested How drugs produce effect
- 15. Paper Tiger Keyboard Warrior Stadium Spectators
- 16. Drugs are manufactured • Tablet/Capsules • Liquids • Injections • Creams/Ointments Tell more …
- 17. How drugs are manufactured • Manual • Automatic • Hybrid • Robotic
- 18. Drugs are tested • Physically • Chemically • Microbiologically
- 19. How drugs are tested • UV • HPLC • Titration Tell more ….
- 20. Drugs produce effect Treat & manage the disease
- 21. How drugs produce effect By reaching in blood By reaching at site of action Tell more …
- 22. What you don’t know?
- 24. Integrated Affairs Drug applications are reviewed
- 25. Integrated Affairs Drug applications are reviewed RE- VIEW
- 26. Integrated Affairs Drug applications are reviewed Manufacturing facilities are assessed
- 27. Integrated Affairs Drug applications are reviewed Manufacturing facilities are assessed Assessed
- 28. Integrated Affairs Drug applications are reviewed Manufacturing facilities are assessed Diligence & Vigilance walk together
- 30. Global Affairs
- 31. Global Affairs International Council for Harmonization
- 32. Global Affairs International Council for Harmonization Mutual Recognition Agreements
- 33. Global Affairs International Council for Harmonization Mutual Recognition Agreements International Obligations
- 36. Innovation Affairs Evolution of Continuous Manufacturing
- 37. Innovation Affairs Evolution of Continuous Manufacturing Progressive Initiatives on Quality by Design
- 38. Innovation Affairs Evolution of Continuous Manufacturing Progressive Initiatives on Quality by Design Knowledge Aided Structured Application
- 40. Innovation Affairs Gene Therapy Signal Detection
- 41. Innovation Affairs Gene Therapy Signal Detection Precision Medicine
- 45. Pushing Boundaries Aseptic Extemporaneous Compounding Focusing Impurities Encouraging Complaints
- 49. Shape the Future
- 50. De - learn
- 51. Re - learn
- 52. Are you different from other disciplines?
- 53. Strength
- 54. Strength Pharmaceutical Sciences Regulatory Sciences Healthcare Professional
- 55. Weakness Mathematics & Statistics Engineering & Metallurgy Expertise in Fundamental Sciences
- 56. Dose this difference has significant impact?
- 57. Strength Pharmaceutical Sciences Regulatory Sciences Healthcare Professional
- 58. Pharmaceutical Sciences • Drug development • Drug dosage • Drug delivery • Drug shelf life • Drug supply
- 59. Regulatory Sciences Tools & Approaches to assess • Drug Safety • Drug Efficacy • Drug Quality • Drug Hazards
- 60. Healthcare Professional • Brand Name Analysis • Therapeutic Drug Monitoring • Rationale Use of Drug • Safety Alert Issuance • Review Labels Claim
- 61. Weakness Mathematics & Statistics Engineering & Metallurgy Expertise in Fundamental Sciences
- 62. Mathematics & Statistics • Rational & Logical • Appropriate Modeling • Trend & Pattern Review • Cross-team Dependent • Poor in Project Management
- 63. Engineering & Metallurgy • Process Control • Cleaning & Maintenance • Consistency & Threats • Facility Qualification • Air & Water Control
- 64. Expertise in Fundamental Sciences • Chemical Reaction Mechanism • Microbiological Handling • Analytical Sciences • Facility Commissioning • FAT & SAT
- 65. How much it is flexible to excellence
- 67. Rational & Logical One lot is of 92% Second lot is of 100% Limit is 95 – 105% Can it be considered 96% as average Tablet Manufacturing ?
- 68. Rational & Logical One lot is of 92% Second lot is of 100% Limit is 95 – 105% Can it be considered 96% as average Tablet Manufacturing
- 69. Rational & Logical One lot is of 92% Second lot is of 100% Limit is 95 – 105% Can it be considered 96% as average Tablet Manufacturing
- 70. Rational & Logical One lot is of 92% Second lot is of 100% Limit is 95 – 105% Can it be considered 96% as average Tablet Manufacturing
- 71. Appropriate Modeling In-process Control Your procedure defines you will weigh 10 tablets altogether at every 15 minutes You will do individual weight at every 2 hours. It seems balanced but ….
- 72. Appropriate Modeling In-process Control Your procedure for syrup testing is to pour whole syrup in cylinder and then take some sample for testing Whereas, it is not representative of spoon that is used by the patient. The procedure seems correct but ….
- 73. Trend & Pattern Review Good pattern of particle size read as good trend for dissolution Ignoring the high variation trend of impurity profile & relying on trend of assay
- 74. Trend & Pattern Review Integration of data with regard to Complaint trend & open investigation pattern is used to identify area where risk prevails to move more efficiently & effectively
- 75. Cross Team Dependent Organic Chemistry, Analytical Chemistry, Physical Chemistry, Mechanical Engineers, Computer Engineers, Microbiologists, Supply Chain Experts, Statisticians, Economist
- 76. Poor in Project Management Leadership, Human Resource Management, Financial Management, Material Management, Inventory Control, Strategic Planning as well as Project Management.
- 77. Process Control Equipment & manufacturing process are critical to control for delivering consistent quality of drugs. Equipment design, working principle, its maintenance plan are interlinked and need collaborative cross team knowledge sharing. Remember if you understand your process & product, you can be trusted for maintaining quality, not otherwise
- 78. Process Control Equipment & manufacturing process are critical to control for delivering consistent quality of drugs. Equipment design, working principle, its maintenance plan are interlinked and need collaborative cross team knowledge sharing. Remember if you understand your process & product, you can be trusted for maintaining quality, not otherwise
- 79. Process Control Equipment & manufacturing process are critical to control for delivering consistent quality of drugs. Equipment design, working principle, its maintenance plan are interlinked and need collaborative cross team knowledge sharing. Remember if you understand your process & product, you can be trusted for maintaining quality, not otherwise
- 80. Cleaning & Maintenance Design of equipment, Process, Material Nature, Dust Generation Potential, Cleaning Agents, Interaction of Cleaning Agents & Equipment, Tools of Cleaning are areas to maintain balance of contamination & cross- contamination
- 81. Consistency & Threats Dosage uniformity, Product stability (associated with manufacturing facility) & Equipment performance Influence of equipment components to unit dose such as punches, filling line, dose metrics.
- 82. Consistency & Threats Dosage uniformity, Product stability (associated with manufacturing facility) & Equipment performance Influence of equipment components to unit dose such as punches, filling line, dose metrics.
- 83. Facility Qualification Impact of season on facility e.g. humidity, hot weather, dust storm, rain, earthquake, building maintenance, paint etc.
- 84. Air & Water Control Air pressure, Containment, Air Particles, Air Filtration, Microbial Controls, Water Qualification, Water Supply, Water Holding, Passivation, Biofilms, etc.
- 85. Chemical Reaction Mechanism How molecule will be synthesized & how it will break & from where it will break. Understanding of chemistry of Drug Substance & Drug Product, influence of various factors on them to design an appropriate control strategy commensurate with risks
- 86. Chemical Reaction Mechanism How molecule will be synthesized & how it will break & from where it will break. Understanding of chemistry of Drug Substance & Drug Product, influence of various factors on them to design an appropriate control strategy commensurate with risks
- 87. Microbiological Handling How to treat the materials, facility & equipment to protect from microbial growth & biodegradation How to identify & characterize the different types of microbes and their source of ingress
- 88. Microbiological Handling How to treat the materials, facility & equipment to protect from microbial growth & biodegradation How to identify & characterize the different types of microbes and their source of ingress
- 89. Analytical Sciences Development of methods & use of techniques to qualify materials, impurities & its dosage performance.
- 90. Facility Commissioning Equipment, utilities & supplies installations as well as complete qualification to see the suitability for intended purpose of its design
- 91. FAT & SAT Verification of performance outside your facility for a machine selected to produce a particular product or group of products in your facility Qualification of machine before commercial manufacturing of product
- 92. FAT & SAT Verification of performance outside your facility for a machine selected to produce a particular product or group of products in your facility Qualification of machine before commercial manufacturing of product
- 93. What you don’t know? What you should know? What do you know? 1 2 3
- 94. Does this difference has significant impact? How much it is flexible to excellence? Are you different from other disciplines? 2 1 3
- 95. Sciences & its Placement in Emerging Pharmaceutical World Regulatory Cloud
- 96. Priority
- 98. Safety Efficacy Quality D R U G
- 100. Pre-Registration Post-RegistrationManufacturing Concept and Animal Studies
- 101. Pre-Registration Post-RegistrationManufacturing Concept and Animal Studies Clinical Studies
- 102. Regulations Protect & Promote Public Health
- 103. Pre-Registration Post-RegistrationManufacturing Consistency Contamination Cross ContaminationMix-up
- 104. Pre-Registration Post-RegistrationManufacturing Consistency Contamination Cross ContaminationMix-up Within Batch Batch after Batch
- 105. Pre-Registration Post-RegistrationManufacturing Consistency Contamination Cross ContaminationMix-up Within Batch Batch after Batch With same product of other batch, or other product or dust, or microbe
- 106. 125% 75% 98% 102%
- 109. 150 lives Pakistan 149 deaths USA Meningitis Outbreak It is 21st Century
- 110. 100’s of Deaths
- 114. Pre-Registration Post-RegistrationManufacturing Pharmacovigilance Quality Surveillance Medication Safety
- 115. The lives of 22,000 patients in USA alone could have been saved if U.S. regulators had been quicker to ban it.
- 117. Pre-Registration Post-RegistrationManufacturing New Drug Generic Drug
- 120. Where does your knowledge stand? Keep an eye on yourself
- 121. Learn, De-learn & Re-learn Thanks