Home » Quality Risk Management for Pharmaceuticals
Quality Risk Management for Pharmaceuticals
October 19, 2015
Each step in the drug manufacturing process involves potential risks to the product quality and,
as a result, to the patient. However, the risks associated with manufacturing are only one part of the overall risk to the drug during its life cycle. This life cycle includes the development of drug substances, the manufacture of drug substances and excipients, the development of the drug, clinical testing, manufacture, marketing and use by patients, and ends with its withdrawal from the market.