Wednesday, 16 October 2013

Embracing quality risk management: The new paradigm


The use of risk assessment in the pharma industry is both an increasingly used tool and an expectation of regulatory authorities. Risk assessment forms a key component of any risk management program. Risk analysis and risk evaluation together represent the two fundamental parts of the risk assessment phase of a risk management process cycle. The assessment of risk involves either the quantitative or qualitative determination of one or more risks. Risks are generally recognized as being related to a situation, event or scenario in which a recognized hazard may result in harm. Quantitative risk assessment requires a type of calculation. This is often based upon the magnitude or severity of the risk and the probability that the risk will occur.

Recently Tim Sandle and Madhu Raju Saghee wrote an article on the drive towards risk based approaches and quality management, including the 'Pharmaceutical cGMPS for the 21st century: A Risk Based Approach' initiative by FDA; Annex 15 to the EU GMP Guide; and the ICH Guideline titled Quality Risk management., (ICH Q9).


To read more about risk management and its application to the pharmaceutical and healthcare sector, go to Express Pharma.