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Hospira (formerly Mayne Pharma), Melbourne, Australia
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Change Control System
| Project Duration: |
August 2003 – November 2003 |
| Project Features: |
Enhancement of change control practices |
| Works Included: |
Review of the system in place, performance of a risk assessment to understand the tasks required to ensure the new process was compliant. |
Project Outline:
- Review the system currently used for Equipment and Facility Change Control.
- Create and update as required existing Standard Operating Procedures, policies and programs.
- Review current responsibility assignments for each major category ensuring roles are adequately defined.
- Ensure the system for notification of the Quality Unit of proposed changes is in place and the roles, responsibilities and authority of the Quality Unit is defined and in place for Equipment and Facility Change Control.
- Review the current training programs and training material associated with equipment and facility change control.
- Develop and implement measurement techniques for the effectiveness of the training programs and training material for Equipment and Facility Change Control.
- Design and implement a system to uniquely identify and track individual Change Requests.
- Establish and assign responsibilities for the centralised Change Control program.
- Establish requirements and controls that ensure the Quality Units participation and oversight of the Change Control process.
- Develop a mechanism that will track and trend all Change Control activities.
Dispensaries Refurbishment & Critical Building Management System (CBMS)
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Project Duration:
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November 2006 – April 2008 |
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Project Features:
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Delivery of 3 dispensary areas, a freezer room, cool-room and associated modifications to the plant Critical Building Management System. |
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Works Included:
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Conceptual design through to process qualification, ensuring the new process was compliant with the FDA, EU and TGA regulatory bodies. |
Project Outline:
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