Журнал глобальных исследований науки и природы
Открытый доступ


Risk Management Methods and Tools for Pharmaceuticals

Vivek P. Chavda, Dharmesh Shaliya, Bhargav Patel and Dr. Moinuddin M. Soniwala

A variety of tools can be used for the purposes of QRM, either alone or in combination. It is important to note that no single tool or combination of tools is applicable to every situation in which a QRM procedure is used. Examples of tools are listed in regulatory guidance; neither list is exhaustive. The important criterion for acceptability is that the tool or tools are used effectively to support the key attributes of a good risk assessment.