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 |