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Pharmaceutical Manufacturing Operations
This document summarizes key points from a talk given to pharmacy students on the science behind drug quality. It discusses how drugs are manufactured, tested, and produce their intended effects. It also covers integrated affairs like drug application reviews and facility assessments. Global affairs like international harmonization are discussed. Innovation topics include continuous manufacturing and quality by design. The document emphasizes that understanding manufacturing processes, analytical sciences, and other disciplines is crucial for maintaining consistent drug quality. It stresses the importance of safety, efficacy and quality throughout the drug development and manufacturing process.
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Pharmaceutical Manufacturing Operations
- 1. Pharmaceutical Manufacturing Operations Sciencebehind Drug Quality (A talk with final year Pharmacy students) Obaid Ali & Roohi B. Obaid 24 Mar 2019
- 2. Current Judgment No obligations Fromexperience & References Personal Point of View DISCLAIMER
- 3. Pharmacy Students Lets recheckthe alignment to keep journey on progressive mode
- 4. What do youknow? 1
- 5. What you don’tknow? What do you know? 1 2
- 6. What you don’tknow? What you should know? What do you know? 1 2 3
- 7. Are you differentfrom other disciplines? 1
- 8. Does this differencehas significant impact? Are you different from other disciplines? 2 1
- 9. Does this differencehas significant impact? How much it is flexible to excellence? Are you different from other disciplines? 2 1 3
- 10. What do youknow?
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- 12. Theory How drugs aremanufactured
- 13. Theory How drugs aremanufactured How drugs are tested
- 14. Theory How drugs aremanufactured How drugs are tested How drugs produce effect
- 15. Paper Tiger KeyboardWarrior 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 Byreaching in blood By reaching at site of action Tell more …
- 22. What you don’tknow?
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- 24. Integrated Affairs Drug applicationsare reviewed
- 25. Integrated Affairs Drug applicationsare reviewed RE- VIEW
- 26. Integrated Affairs Drug applicationsare reviewed Manufacturing facilities are assessed
- 27. Integrated Affairs Drug applicationsare reviewed Manufacturing facilities are assessed Assessed
- 28. Integrated Affairs Drug applicationsare reviewed Manufacturing facilities are assessed Diligence & Vigilance walk together
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- 31. Global Affairs International Councilfor Harmonization
- 32. Global Affairs International Councilfor Harmonization Mutual Recognition Agreements
- 33. Global Affairs International Councilfor Harmonization Mutual Recognition Agreements International Obligations
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- 36. Innovation Affairs Evolution ofContinuous Manufacturing
- 37. Innovation Affairs Evolution ofContinuous Manufacturing Progressive Initiatives on Quality by Design
- 38. Innovation Affairs Evolution ofContinuous Manufacturing Progressive Initiatives on Quality by Design Knowledge Aided Structured Application
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- 41. Innovation Affairs Gene Therapy SignalDetection Precision Medicine
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- 45. Pushing Boundaries Aseptic Extemporaneous Compounding FocusingImpurities Encouraging Complaints
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- 52. Are you differentfrom other disciplines?
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- 55. Weakness Mathematics & Statistics Engineering& Metallurgy Expertise in Fundamental Sciences
- 56. Dose this differencehas significant impact?
- 57.
- 58. Pharmaceutical Sciences • Drugdevelopment • 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 • BrandName 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 itis flexible to excellence
- 67. Rational & Logical Onelot is of 92% Second lot is of 100% Limit is 95 – 105% Can it be considered 96% as average Tablet Manufacturing ?
- 68. Rational & Logical Onelot is of 92% Second lot is of 100% Limit is 95 – 105% Can it be considered 96% as average Tablet Manufacturing
- 69. Rational & Logical Onelot is of 92% Second lot is of 100% Limit is 95 – 105% Can it be considered 96% as average Tablet Manufacturing
- 70. Rational & Logical Onelot 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 Yourprocedure 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 Yourprocedure 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 & PatternReview 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 & PatternReview 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 OrganicChemistry, 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 Designof 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 Dosageuniformity, 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 Dosageuniformity, 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 ofseason on facility e.g. humidity, hot weather, dust storm, rain, earthquake, building maintenance, paint etc.
- 84. Air & WaterControl Air pressure, Containment, Air Particles, Air Filtration, Microbial Controls, Water Qualification, Water Supply, Water Holding, Passivation, Biofilms, etc.
- 85. Chemical Reaction Mechanism How moleculewill 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 moleculewill 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 totreat 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 totreat 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 ofmethods & 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 Verificationof 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 Verificationof 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’tknow? What you should know? What do you know? 1 2 3
- 94. Does this differencehas significant impact? How much it is flexible to excellence? Are you different from other disciplines? 2 1 3
- 95. Sciences & itsPlacement in Emerging Pharmaceutical World Regulatory Cloud
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- 101. Pre-Registration Post-RegistrationManufacturing Concept andAnimal Studies Clinical Studies
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- 103. Pre-Registration Post-RegistrationManufacturing Consistency ContaminationCross ContaminationMix-up
- 104. Pre-Registration Post-RegistrationManufacturing Consistency ContaminationCross ContaminationMix-up Within Batch Batch after Batch
- 105. Pre-Registration Post-RegistrationManufacturing Consistency ContaminationCross ContaminationMix-up Within Batch Batch after Batch With same product of other batch, or other product or dust, or microbe
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- 109. 150 lives Pakistan 149 deaths USA Meningitis Outbreak Itis 21st Century
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- 115. The lives of22,000 patients in USA alone could have been saved if U.S. regulators had been quicker to ban it.
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- 120. Where does yourknowledge stand? Keep an eye on yourself
- 121. Learn, De-learn &Re-learn Thanks