Change control is another well-know concept that focuses on managing change to prevent unintended consequences. The regulations provide for change control primarily through the assigned responsibilities of the quality control unit. Certain major manufacturing changes (e.g., changes that alter specifications, a critical product attribute) might require regulatory filings and prior regulatory approval. Effective change control activities (e.g., quality planning and control of revisions to specifications, process parameters, procedures) are key components of any quality system. There are regulatory guidances that explain changes and in these guidances change is discussed in terms of creating a regulatory environment that encourages change towards continual improvement. This means a manufacturer is empowered to make changes subject to the regulations based on the variability of materials used in manufacturing and process improvements resulting from knowledge gained during a product’s lifecycle. Based on my 13+ years of experience, I believe it is practically impossible to avoid changes during product development and post market. Therefore, the better the change is documented (evaluation against the basis and documented tests to ensure any implemented risk control measures do not introduce new unforeseen risks, etc.) the better the project team will be able to handle the change at hand.