It goes without saying that upgrades during a manufacturing shutdown pose less risk as there are no products being produced, but there are instances when it is critical to expand capacity or modify functionality while maintaining some processing. For example:

  • Manufacturers upgrade certain areas while maintaining process operations on adjacent lines
  •  Companies reconfigure equipment or add modular, flexible capabilities for the future
  • New or established manufacturers increase capacity incrementally while keeping supply on the market (and revenue flowing)

As George Wiker, Executive Director at AES Clean Technology, Inc.® [1], explains, these upgrades are a challenge for a variety of reasons. It is critical to maintain control of production and changes—and demonstrate proof of control—while keeping the involved workers and the products safe.

It is also important to note that a company will need to revalidate any system modified during a facility change, and the extent of the change may also require a re-inspection by the FDA.

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Original Publication Date: 12/2016