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Home Manual Details
Author:
WAHO
Category:
Quality Management Systems
Language:
English
Date Updated:
9/22/2020 8:56:12 AM
Description
To describe and outline the activities required in initiating, planning, implementing, managing change and obtaining approval for intended or planned changes to ensure effective implementation of changes in a controlled and coordinated manner.
Abstract
1.0 Purpose To describe and outline the activities required in initiating, planning, implementing, managing change and obtaining approval for intended or planned changes to ensure effective implementation of changes in a controlled and co-ordinated manner. 2.0 Scope This SOP applies to all types of planned changes that have the potential to affect the accuracy and reliability of test results in quality control laboratories for medicines in the West African region. 3.0 Responsibility The Change Originator and the Quality Assurance Manager are responsible for carrying out the administrative activities associated with obtaining approval for the change and the ultimate approval and implementation of the changes. The head of laboratory is responsible for the overall monitoring and coordination of change process for the laboratory. 4.0 Reference: WHO- Good Practices for National Pharmaceutical Control Laboratories (Part three -14) ISO/IEC 17025:2017 Clause 5.7, 7.1 ,7.2 ,7.8,7.11,8.3,8.7,8.8,8.9
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