Q1C Stability Testing for New Dosage Forms | Guideline Explorer

Description

This document is an annex to the ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and Products and addresses the recommendations on what should be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new drug substances and products.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

1

New Dosage Form

A new dosage form is defined as a drug product which is a different pharmaceutical product type

Regulatory Context

Regulatory Activities

1

Original application

submitted regarding stability of new dosage forms by the owner of the original application

Document Types

1

Stability protocols

Documentation outlining the plan for stability testing

Technical Details

Substances

1

Active substance

provide the active substance as it appears in the FDA SRS UNII list

Processes

1

Stability Testing

Primary process described in the guideline; Core activity described in the guidance; General process for evaluating product quality over time; Formal stability studies to assess adjuvant stability; Evaluation of attributes at all storage conditions; The process of evaluating product quality over time under specified conditions.; Evaluation of product quality over time

Standards & References

Specifications

1

Reduced stability database

a reduced stability database at submission time (e.g., 6 months accelerated and 6 months long-term data)

ICH References (2)

Stability Testing of New Drug Substances and Products

Referenced for drug substance stability information.; Detailed guidance on stability may be found in Stability Testing of New Drug Substances and Products, 10/27/93; ICH Guideline reference

ICH Q1C

Stability Testing for New Dosage Forms

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