変更管理とは？（EP抜粋）
43. Written procedures should be in place to describe the actions to be taken if a
change is proposed to a starting material, product component, process
equipment, process environment (or site), method of production or testing or
any other change that may affect product quality or reproducibility of the
process. Change control procedures should ensure that sufficient supporting
data are generated to demonstrate that the revised process will result in a
product of the desired quality, consistent with the approved specifications.
44. All changes that may affect product quality or reproducibility of the process
should be formally requested, documented and accepted. The likely impact
of the change of facilities, systems and equipment on the product should be
evaluated, including risk analysis. The need for, and the extent of, requalification
and re-validation should be determined.
© Rakuten Group, Inc.
