《10Step–ToolGuidance-英文》.pptVIP

How to use this Presentation: Purpose of this presentation: This presentation gives Guidance to users on each Step of the GMP Risk Management tool It attempts to answer some common questions which may arise when using the tool.. so, this is mainly a QA Document How to make the most out of these slides: When performing a GMP Risk Management exercise with this tool, each participant of the team should have a paper copy of these slides for reference When at a particular Step of the tool, the corresponding slides for that Step can be checked and consulted for Guidance Guidance for Step 1 – Preliminary Info What is Step 1 about? Page 1 of Step 1 is where we define the purpose of the RM exercise, and here also we state what is being studied (e.g. a Manufacturing Process). Page 2 is where we scope out the RM exercise, and it is where we state the reason for the exercise. Selecting from the available three Options in Step 1 Options 1 and 3 are similar in that they both relate to Change Controls, but Option 3 goes beyond looking merely at the Q V requirements associated with a proposed Change, as it assesses the change control from a broader viewpoint… it asks “If we implement the proposed change, what risks does it present?” Option 1 2 cannot both be selected at one time. Guidance for Step 1 – Preliminary Info What could a Specific Issue or Problem look like in Step 1? This could be something such as glass in vials, a series of batch rejects due to high impurity levels, a product recall issue, etc. What is meant by “Item Under Study” in Step 1? This is just the term used in the tool to refer to the subject of the Risk management exercise. Guidance for Step 1 – Preliminary Info What kind of info do we record under “Reason Relevant Background Info”? Under “Reason Relevant Background Info” give as much useful info as possible on why we are doing this exercise. It can be useful here to think in terms of a Risk Question, or in terms of a Problem Description when co