Drug “contamination” refers to the undesired introduction of impurities (of a chemical or microbiological nature) or foreign matter, into or onto a starting material, intermediate product, or finished product during production, sampling, packaging or re-packaging or during storage or transport.
Complex Process
It is important to know that drug manufacturing is a complex process made up of processing steps using a variety of process equipment and support systems within the manufacturing facility.
Risk of Contamination
Each process unit step, equipment, or system has its impact on product quality, and can pose a risk of contamination.
