Transcription of Developing, Issuing and Maintaining Standard …
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Developing, Issuing and Maintaining Standard …
MANUAL OF POLICIES AND procedures CENTER FOR DRUG EVALUATION AND RESEARCH MAPP Originating Office: Office of Management Effective Date: 01/12/15 Page 1 of 6 POLICY OFFICE OF MANAGEMENT developing , Issuing and Maintaining Standard operating procedures for CDER Table of Contents PURPOSE ..1 BACKGROUND ..1 POLICY ..2 RESPONSIBILITIES ..3 DEFINITIONS ..3 REFERENCES ..4 EFFECTIVE DATE ..4 CHANGE CONTROL TABLE ..4 ATTACHMENT 1: Guidelines to differentiate MAPPs from SOPs ..5 PURPOSE This MAPP specifies the factors to consider when making a determination on whether to develop a Manual of Policies and procedures (MAPP) or a S tandard operating Procedure (SOP) when delineating CDER policies and procedures .
Standard Operating Procedure (SOP) – A policy or procedure that generally applies to the internal functioning of a single office and refers to subject matter that is presumably
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