The application of Risk Management methodologies is the biggest change to be presented to the pharmaceutical industry in recent years.
Driven by the FDA through the initiative 'cGMPs for the 21st Century: A Risk-Based Approach' and the inclusion of ICH Q9 as Annex 20 in the EU GMP code, the use of risk management is applicable to all parts of the pharmaceutical product lifecycle and supply chain.
Understanding and addressing risk in a structured manner delivers improved product quality and ensures that valuable resources are used for things that are important, not wasted on things that are not. |
