Transcription of Standard Operating Procedure - GMPSOP
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Standard Operating Procedure - GMPSOP
Standard Operating Procedure Title: Quality Risk management Techniques Department Quality management Document no QMS-135. Title Quality Risk management Techniques Prepared by: Date: Supersedes: Checked by: Date: Date Issued: Approved by: Date: Review Date: Purpose This SOP defines the approach to Quality Risk management (QRM) of a GMP site and gives practical examples for tools which may be used to facilitate the process and to aid personnel performing the assessment. Scope Applicable to any process at a GMP site which requires a Risk management approach.
management and those operating the process or system who may be affected by those results. This requires that each step of the risk management process be documented at an appropriate level. The purpose of the output from the risk management process is: To share and communicate information about the risks and how they are controlled.
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