FDA Releases SUPAC Guidance - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Releases SUPAC Guidance


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has released a draft guidance of scale-up and post-approval changes that combines and supersedes previous guidance documents: SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum and SUPAC-SS Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum. FDA states that the new draft SUPAC addendum should be used in combination with the other SUPAC guidance documents.

This draft guidance, Guidance for Industry SUPAC: Manufacturing Equipment Addendum, Draft Guidance, removes the lists of manufacturing equipment that were in the previous guidance documents and clarifies the types of processes being referenced. It defines levels of chemistry, manufacturing, and control change; recommended chemistry, manufacturing, and controls tests for each level of change; recommended in vitro dissolution and release tests and/or in vivo bioequivalence tests for each level of change; and recommended documentation that should support the change for new drug applications and abbreviated new drug applications.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here