Description
This guidance recommends that abbreviated new drug applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act, and the drug master files (DMFs) that support ANDAs, follow the stability recommendations provided in the International Conference on Harmonisation (ICH) stability guidances.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1RTRT and CTD sections apply to drug products
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Regulatory Activities
1Abbreviated New Drug Application
Document Types
1A submission to FDA that may be used to provide confidential information about facilities or processes.; cross-referencing a DMF in a BLA
Attributes
2two pilot scale batches and one small scale batch
Submit data from three pilot scale batches
Technical Details
Substances
1Postapproval changes to drug substances; the active pharmaceutical ingredient being modified; Evaluation of physical properties for drug substance; Active ingredient intended to furnish pharmacological activity; The molecule or ion responsible for the physiological or pharmacological action.; The active pharmaceutical ingredient subject to postapproval changes
Testing Methods
1plan for evaluating equivalent or improved performance
Processes
1Manufacture and package the drug product using principles representative of the commercial process
Standards & References
Specifications
225±2°C, 60±5% RH
6 months of data that include accelerated and long-term conditions
ICH References (5)
Evaluation of Stability Data
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Stability Testing for New Dosage Forms
Photostability Testing of New Drug Substances and Products
Stability Testing of New Drug Substances and Products
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2