Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective.

Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective.

Is it Essential to Sequence the Entire 16S rRNA Gene for Bacterial Identification? | American Pharmaceutical Review (Nov/Dec 2015)

Bacterial Identification in the biopharmaceutical industry, especially in manufacturing facilities, is very important because an occurrence of a problematic microorganism in the final product could be harmful for the end user and detrimental to a company’s finances and reputation. Environmental Monitoring (EM) programs are the cornerstone of understanding the microbial ecology in a manufacturin...

Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines

Background Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India’s pharmaceutical industry and its large export market makes the problem more acute.   Methods The foc...

Process analytical technology (PAT) needs and applications

Title Process analytical technology (PAT) needs and applications in the bioprocess industry Review Abstract Process analytical technologies have been applied to manufacturing processes (pulp and paper, chemical and petroleum) for decades. Recently, the US Food and Drug Administration (FDA) has, however, redefined the phrase and implemented it into an initiative focusing on improving several asp...

Perspective of the Future of Pharmaceutical Technology in Iran

Pharmaceutical industry is currently undergoing a transient phase with new orientation. Loss of financial resources, presence of new therapeutic agents and increasing cost of research and development have called for a full.scale restructuring within the pharmaceutical industry to retain even the most basic competitiveness. The development of new technologies has been as one way out of the dile...