Implementing A Structured And Organised Fashion

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When a major development is introduced in to the laboratory a number of key factors such as processes, equipment, personnel, premises and documentation need to be considered. In order to consider these factors in a structured and organised fashion, a project plan with clear objectives and validation requirements for the project should be undertaken.
The project plan should also include information on the team that will be involved in the project, any resources that are required, specific tasks that need to be completed and a time scale for each section of the project. As a result, the project plan provides the appropriate procedures to ensure that a safe and high quality service will be provided throughout the implementation of the major development.5
In order to formulate the project plan, the relevant guidelines and regulations should be consulted. The guidelines vary depending on the type of laboratory the project is being undertaken in as different areas of transfusion, transplantation and tissue banking are accredited by different regulatory bodies. The Eudralex Volume 4 (GMP) is a European directive, which is translated into the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (2014), commonly referred to as “the Orange Guide”. This is a key reference for anyone who manufactures and distributes medicines within Europe so that good manufacturing practice can be established.13 Transfusion laboratories refer to the Blood Safety and Quality

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