Change Control: New SUPAC Guidance published

The U.S. Food and Drug Administration (FDA) has published a new draft Guidance for Industry: SUPAC - Manufacturing Equipment Addendum. The guidance document is being distributed for comment purposes.

The draft guidance combines and supersedes the following two Scale-up and Post-approval Changes (SUPAC) Guidances for industry:

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

This draft SUPAC addendum, together with the SUPAC guidances, gives guidance to the manufacturer determining the documentation which needs to be submitted to FDA regarding manufacturing equipment changes. It lists various kinds of manufacturing equipment with the respective description and equipment classification and clarifies the types of processes being referenced.

What are Scale-up and Post-approval Changes (SUPAC) Guidance Documents? They give recommendations to the pharmaceutical manufacturer in case of changes with respect to:

  • Composition and Ingredients
  • Process and equipment
  • Batch size
  • Manufacturing site

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance: www.regulations.gov.

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