Introduction
In this workshop, we are establishing what items within our clean in place system need validating. A Component Level Impact Assessment happens at the start of the validation project and what you decide here will determine the validation activities. You are looking to establish the critical and non-critical items within our clean in place system.
For items you determine to be critical, you must then decide if they are product-contact critical or operationally critical. You also have to be able to give a rationale for your decision.
As outlined previously, if non-critical items are validated, the cost of manufacturing increases (leading to unaffordable medicines for patients). So it’s crucial that you can see the decision making process and understand how we reach the point where we are validating the things that are essential in ensuring a safe and effective product, without over-validating.
Component Level Impact Assessment
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Component Level Impact Assessment
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