Reduction in changeover activities in Pharmaceutical

Industrial Management Consulting
Industrial Management Consulting

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With robust risk assessments, companies can provide a solid defense that can support reduction in changeover activities. This may include the following:

● Elimination or reduction of elastomer change-out
● Elimination or reduction of changeover sampling
● Reduction of line clearance activities
● Concurrent manufacture of multiple products within a single manufacturing area

It is important to realize that, if using risk assessment to justify a reduction in changeover, the risk assessment must be defendable.  By building up technical documents to support this defense, it is possible to demonstrate control while minimizing activities.

Figure 2 is an overview of the types of defenses that can be established to support a reduced changeover effort. Each of the elements in the diagram is discussed in the following sections.

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Continue at: https://www.biophorum.com/wp-content/uploads/2018/03/2018-Guidelines-for-risk-based-change-over-of-biopharma-mult-product-facilities.pdf

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