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Change Notification Management

It is a requirement of GMP that customers are confident that products used in their validated workflows will not change without their prior knowledge, so that they can perform a risk assessment of the product change and determine whether it has any impact on the quality or consistency of the final product.

Fisher Scientific Product Change Notification (PCN) service guarantees advance notice of potential changes impacting listed critical materials across a broad range of our customers’ product needs.

Product changes include:

  • Product discontinuations
  • Changes to the manufacturing site
  • Any other changes that might impact the quality, form, fit, or function of the product

Our customers will benefit from:

  • Provision of documents to support risk assessment
  • Where needed, support in identifying alternative product

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