SUPAC: Manufacturing Equipment Addendum (FDA Final Guidance, December 2014)

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FDA has issued the final guidance SUPAC: Manufacturing Equipment Addendum. This final guidance combines and supersedes the following scale-up and post-approval changes (SUPAC) guidances for industry: (1) SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum, and (2) SUPAC-SS Non-sterile Semisolid Dosage Forms, Manufacturing Equipment Addendum. It removes the lists of manufacturing equipment that were in both guidances and clarifies the types of processes being referenced.

This SUPAC addendum should be used in conjunction with the following SUPAC guidances for  industry: (1) Immediate Release Solid Oral Dosage Forms — Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation, (2) SUPAC-MR: Modified Release Solid Oral Dosage Forms 30 Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, and (3) SUPAC-SS: Non-sterile Semisolid Dosage Forms, Scale-Up and Post Approval Changes: Chemistry Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation.

The SUPAC guidances define: (1) levels of chemistry, manufacturing, and control change; (2) recommended chemistry, manufacturing, and controls tests for each level of change; (3) recommended in vitro dissolution and release tests and/or in vivo bioequivalence tests for each level of change: and (4) recommended documentation that should support the change for NDAs and ANDAs.

Read the final guidance here.