Microbiological Quality Control and Assurance of Pharmaceuticals
- Course Code :
PMI 877
- Level :
Postgraduate
- Course Hours :
2.00
Hours
- Entry year :
2022/2023
- Department :
Faculty of Pharmacy
Aim of the course
Course Contents
This course deals with contamination, spoilage of pharmaceuticals and their control. Enumeration and identification of microorganism using both traditional and rapid methods as well as the pharmacopaeial methods for detection of the specified organism. Bioburden testing, pharmacopial methods for microbial limit of non sterile products. Examination of sterile and non sterile products, validation of the above processes. Bacterial endotoxins/pyrogens detection and depyrogenation Processes. Microbiological quality assurance of water and environmental monitoring. Pharmacopial, industrial and governmental regulations and guidelines for quality assurance