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Table 4 Relevant Globally Harmonized ICH Guidelines Applicable to Combination Products

From: Stability considerations for drug-device combination products-21 CFR part 4 update

Guideline Title

Guideline Content

Q1A(R2) – Stability Testing of New Drug Substances and Products

Prescriptive requirements for accelerated and long-term stability study design

Q1B – Stability Testing: Photostability Testing of New Drug Substances and Products

Prescriptive requirements for photostability study design

Q1D – Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Prescriptive requirements for stability study representative product selection designs where every iteration of the product family is not planned to be evaluated

Q1E – Evaluation for Stability Data

Prescriptive requirements for presenting, analyzing, and drawing conclusions from stability data

Q2(R1) – Validation of Analytical Procedures: Text and Methodology

Prescriptive requirements for stability indicating procedures

Q3A – Q3E—Impurities

A series of prescriptive requirements for stability evaluation of degradants, impurities, and residual solvents, including requirements for extractables and leachables

Q4B – Q3E – Pharmacopoeias and Annexes

A series of the prescriptive test methods

Q6A – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

Defines the concepts of release testing versus stability testing specifications and parametric release versus sterility testing. Additionally, it prescriptively describes the tests and acceptance criteria generally applicable to all new drug products