Description
Sterile dosage forms are defined as preparations intended for injection through the skin or other external boundary tissue. Sterile drug products are the dosage forms that are administered directly into the blood stream or body tissue. Sterile dosage forms are manufactured with extreme care by procedures designed to ensure that pharmacopeial requirements. Sterile manufacturing operations require mechanical excellence, sanitization, and sterilization. Manufacturing types for sterile drug products are aseptic manufacturing and terminal sterilization. In the scope of this course, most important characteristics of the sterile drug product, manufacturing techniques of sterile drug products and quality requirements of sterile manufacturing have been discussed. COURSE AGENDA1 Introduction2 Introduction to Sterile Drug Manufacturing 2.1. Introduction to Sterile Drug Manufacturing 2.1.1. Pharmaceutical Drug Product 2.1.2. Pharmaceutical Drug Substance 2.1.3. Pharmaceutical Dosage Forms 2.1.4. Quality Requirements of Pharmaceutical Drug Product 2.1.5. Quality Requirements of Pharmaceutical Sterile Drug Product 2.1.6. Pharmaceutical Sterile Drug Product Manufacturing 2.2. Basic Definitions - 1 for Sterile Drug Manufacturing 2.2.1. Standart Operating Procedure (SOP) 2.2.2. Batch Record 2.2.3. Master Record 2.2.4. Specification 2.3. Basic Definitions - 2 for Sterile Drug Manufacturing 2.3.1. Clean Area 2.3.2. Clean Room 2.3.3. Contamination 2.3.4. Cross-Contamination 2.4. Basic Definitions - 3 for Sterile Drug Manufacturing 2.4.1. HVAC (Heating, Ventilation, and Air-Conditioning) 2.4.2. Airlock 2.4.3. Airlock Types (Personnel & Material) 2.4.4. Airlock Types (Pressure Movement) 2.4.5. Laminar Flow 2.5. Basic Definitions - 4 for Sterile Drug Manufacturing 2.5.1. Calibration 2.5.2. Qualification 2.5.3. Types of Qualification 2.5.4. Validation 2.5.5. Types of Validation 2.6. Basic Definitions - 5 for Sterile Drug Manufacturing 2.6.1. Aseptic Processing Facility 2.6.2. Bioburden 2.6.3. Disinfection 2.6.4. Endotoxin (Pyrogen) 2.6.5. Depyrogenation 2.7. Basic Definitions - 6 for Sterile Drug Manufacturing 2.7.1. Filter Sterilization 2.7.2. Heat Sterilization 2.7.3. Radiation Sterilization 2.7.4. Ethylene Oxide Gas Sterilization 2.8. Basic Definitions - 7 for Sterile Drug Manufacturing 2.8.1. Personnel Monitoring 2.8.2. Non Viable Particulate Monitoring 2.8.3. Surface monitoring 2.8.4. Active air monitoring 2.8.5. Passive air monitoring 3 Characteristics of Sterile Drug Product 3.1. Characteristics of Sterile Drug Product 3.2. Safety 3.3. Sterility 3.4. Stability 3.5. Compatibility 3.6. Nonpyrogenic 3.7. Particle Free 3.8. Tonicity 4 Classification of Sterile Drug Product 4.1. Sterile Dosage Forms & Classification of Sterile Product 4.2. Small Volume Parenterals (Injections) 4.3. Large Volume Parenterals (Infusions) 4.4. Special Sterile Dosage Forms 5 Packaging Selection for Sterile Drug Product 5.1. Primary Packaging and Container Systems of Sterile Product 5.2. Ampoule 5.3. Vials / Bottles 5.4. Syringes 6 Quality Assurance for Sterile Drug Product Manufacturing 6.1. Quality Requirements for Sterile Drug Product Manufacturing 6.2. Documentation for Sterile Drug Product Manufacturing 7 Overview to Sterile Drug Product Manufacturing 7.1.1. Sterile Drug Product Manufacturing Process Types 7.1.2. Terminal Sterilization 7.1.3. Aseptic Process (Sterilisation by Filtration) 8 Aseptic Sterile Drug Product Manufacturing 8.1. Aseptic Process 8.2. Aseptic Manufacturing Qualification and Validation Requirements 8.3. Aseptic Production Process Validation Studies 9 Conclusion
