Standard Operating Procedure for Handling Stability Issues in ANDA Submissions
1) Purpose
The purpose of this SOP is to establish a procedure for addressing stability issues in Abbreviated New Drug Applications (ANDA) submissions to the US FDA to ensure compliance with regulatory requirements.
2) Scope
This SOP applies to all ANDA submissions where stability data is required. It is relevant to departments involved in quality control, quality assurance, regulatory affairs, and production.
3) Responsibilities
- Regulatory Affairs Team: Identifies and addresses stability issues in ANDA submissions.
- Quality Assurance (QA) Team: Reviews and approves stability data and reports.
- Quality
Control (QC) Team: Provides validated data for ANDA submissions.
4) Procedure
- Identification of Stability Issues
- Review stability data to identify any issues that may impact the ANDA submission.
- Document and communicate any discrepancies, deviations, or out-of-specification results.
- Resolution of Stability Issues
- Investigate the root cause of any identified issues, such as formulation changes, packaging modifications, or environmental conditions.
- Develop a corrective action plan to address the identified stability issues.
- Investigate the root cause of any identified
- Data Analysis and Reporting
- Analyze the updated stability data to confirm resolution of the issues.
- Prepare a report detailing the corrective actions taken and submit it to the FDA as part of the ANDA package.
5) Abbreviations, if any
- ANDA: Abbreviated New Drug Application
- QC: Quality Control
- QA: Quality Assurance
6) Documents, if any
- Stability Data Review Report
- Corrective Action Plan
- ANDA Submission Documentation
7) Reference, if any
- FDA Guidance for Industry: ANDA Submissions – Stability Testing of Drug Substances and Products
8) SOP Version
Version 1.0