An NSF International Company Draft SUPAC Manufacturing Equipment Addendum
Thursday the 4th April 2013
In April 2013 the FDA released a draft guidance of scale-up and post-approval changes that combines and supersedes the following previous SUPAC guidance documents:
- SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum
- and SUPAC-SS Non-sterile Semi-solid Dosage Forms, Manufacturing Equipment Addendum.
The FDA stated that the new draft SUPAC addendum should be used in combination with the other SUPAC guidance documents.
This draft guidance removes the lists of manufacturing equipment that were in the previous guidance documents and clarifies the types of processes being referenced.
This draft guidance can be found at: Draft FDA SUPAC Equipment Addendum Apr 2013
