Sterile Drug Product Manufacturing in Pharma Industry

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.