Sterile Drug Product Manufacturing in Pharma Industry

Partner: Udemy
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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. Lam
Category: Teaching & Academics > Science > Pharmaceutical Industry
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Price: 24.99
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Source: Impact
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