Which type of change can be submitted without an updated batch record for a modified release product?

The deletion of color or flavor from a modified release product is a change that can typically be submitted without necessitating an updated batch record because it does not impact the core formulation or the mechanism of release of the active ingredient. Such component changes are often considered minor modifications that do not alter the product's safety, effectiveness, or quality significantly, and as such, regulatory authorities may allow for their implementation with simpler documentation.

In contrast, changes to equipment, processes, or manufacturing sites often require more rigorous documentation and validation because they can affect the overall production consistency, product quality, or compliance with regulatory standards. For instance, an alternate piece of equipment—even if it has the same design—might have variances in performance that could affect the final product. Similarly, substantial adjustments to processes or moving to a different site, even within the same campus, often require a full assessment and updated documentation to ensure the continued reliability and integrity of the product.