FDA Publishes Q&A to Support Guidance, ANDAs: Stability Testing of Drug Substances and Products

FDA has issued this Q&A document because they received over 50 questions from key stakeholders concerning the Draft Guidance Document.

The guidance addresses general issues and specific questions regarding stability testing recommendations as they relate to drug substance master files, drug product manufacturing and packaging, and amendments to pending ANDA applications. The guidance discusses general issues; drug master files (DMFs); drug product manufacturing and packaging; and stability studies that are intended to clarify the stability testing data recommendations for abbreviated new drug applications (ANDAs).  There are questions answered about alternate suppliers, what constitutes small scale, whether GMP is required for small scale stability batches, etc.

Read the full document here.