Risk management is nothing but the identification, assessment, and prioritization of risks. Risks may be associated with uncertainty in financial markets, project failures, legal liabilities, credit risk, accidents, natural causes and disasters as well as deliberate attacks from an adversary. The strategies to manage risk includes transferring the risk to another party, avoiding the risk, reducing the negative effect of the risk and accepting some or all of the consequences of a particular risk. Various aspects of risk management standards have come under denigration for having no measurable or remarkable perfection on risk even though the confidence in estimates and decisions increase. The ICH-Q9 guideline with reference to Quality Risk Management in the pharmaceutical field (active substances and medicinal products) was adopted by the European Union and PIC/S in Annex. 20 of the EU and PIC/S GMP Guides. It is regularly being applied by drug manufacturers in particular as regards sections 1.5 and 1.6 of part I of the aforesaid.
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