Guideline on Summary of requirements for active substances in the quality part of the dossier
Guideline on manufacture of the finished dosage form
ICH Q3B (R2) Impurities in new drug products
ICH Q3C (R8) on impurities: guideline for residual solvents
ICH Q3D (R1) on elemental impurities
Specifications and control tests on the finished product
ICH Q2 (R1) Validation of analytical procedures: Text and methodology
Guideline on the quality of water for pharmaceutical use
Guideline on plastic immediate packaging materials
ICH Q1B - Stability testing: photostability testing of new drug substances and products
ICH Q1E - Evaluation of stability data
Guideline on declaration of storage conditions
Note for Guidance on in-use stability testing of human medicinal products
Note for Guidance on start of shelf-life of the finished dosage form
Guideline on plastic immediate packaging materials
ICH guideline Q8 (R2) on pharmaceutical development
ICH Q10 on pharmaceutical quality system
ICH Q8, Q9 and Q10 – questions and answers volume 4
Note for Guidance on development pharmaceutics
Guideline on the pharmaceutical quality of inhalation and nasal products
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices