Description
This guidance provides recommendations on what chemistry, manufacturing, and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting.
Scope & Applicability
Product Classes
2Drug products referencing a reference listed drug; Proposed products seeking approval via ANDA.
The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences
Stakeholders
3Entity submitting development data and knowledge; Entity performing the work process for change
Entities responsible for developing robust manufacturing processes.
Assist sponsors in the nonclinical evaluation
Regulatory Context
Attributes
1factor used to prioritize evaluation of at-risk drug products; Used to calculate concentration limits in ppm
Related CFR Sections (1)
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
See Also (8)
- Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (Status: Final)
- ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for Industry (Status: Final)
- ANDAs: Impurities in Drug Substances: Guidance for Industry (Status: Final)
- FDA Oversight of PET Drug Products -- Questions and Answers (Status: Final)
- ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits: Guidance for Industry (Status: Final)
- ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry (Status: Final)
- Evaluation of Therapeutic Equivalence (Status: Draft)
- Advanced Manufacturing Technologies Designation Program (Status: Final)