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ICH Q3D Elemental Impurities
ICH Q3D Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for 24 Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of administration. In addition, guidance is provided in Q3D on how to develop an acceptable level for EIs for drug products administered by other routes of administration.
In March 2019, the Q3D(R1) Guideline, which was the result of a revision of the PDE level for Cadmium by inhalation in the Q3D Guideline, reached Step 4 of the ICH process.
Legal effective date: 29/03/2019
ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation
This topic was endorsed by the Assembly in June 2018.
The Q2(R2)/Q14 EWG will develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures, with a view to potentially combine both documents into one, for simplification and clarity.
Q14 Analytical Procedure Development Guideline:
The new guideline is proposed to harmonise the scientific approaches of Analytical Procedure Development, and to provide the principles relating to the description of Analytical Procedure Development process. This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.
Step 1
ICH Q3E: Guideline for Extractables and Leachables (E&L)
Further to the MC's endorsement of the Q3E Concept Paper and Business Plan in July 2020, the Q3E EWG was established to work on the development of the Q3E Guideline on the assessment and control of extractables and leachables (E&L), and is expected would assist both
applicants and regulators by providing focus on critical aspects, and improving transparency in requirements for medicinal products including drug delivery device components.
Step 1