Change Control: New FDA Expectations for Equipment Changes

The U.S. Food and Drug Administration (FDA) has published a new Manufacturing Equipment Addendum for the SUPAC Guidelines (Scale-up and post-approval changes), describing the administration's expectations when assessing manufacturing equipment changes.

This Guidance for Industry combines and supersedes the following Guidances:

• SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum
• SUPAC-SS: Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum

The biggest alteration was the removal of the lists of specific manufacturing equipment that were in both guidances. It now contains general information on SUPAC equipment. The reason is that FDA was concerned that misinterpretation of the lists could discourage advancements in manufacturing technologies.

Furthermore, it clarifies the types of processes being referenced. The information in the document is presented in broad categories of unit operation. For each operation, equipment is categorized by class (operating principle) and subclass (design characteristic). Examples of types of equipment, but not specific brand information, are now given within the subclasses.

When assessing manufacturing equipment changes; FDA recommends to follow "a risk-based approach that includes a rationale and complies with the regulations, including the cGMP regulations". They also recommend "addressing the impact on the product quality attributes of equipment variations (via process parameters) when designing and developing the manufacturing process".