New ICHQ14 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. ICHQ14 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.
This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. The systematic approach suggested in ICH Q8 Pharmaceutical Development together with principles of ICH Q9 Quality Risk Management can also be applied to the development and lifecycle management of analytical procedures. When developing an analytical procedure, a minimal (also known as traditional) approach or elements of an enhanced approach can be applied.
Furthermore, the guideline describes considerations for the development of multivariate analytical procedures and for real time release testing (RTRT).
This guideline is intended to complement ICH Q2 Validation of Analytical Procedures. Submitting knowledge and information related to development of analytical procedures to regulatory agencies may provide additional evidence to demonstrate that the analytical procedure is appropriate for its intended purpose.
Using the tools described in ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, the guideline describes principles to support change management of analytical procedures based on risk management, comprehensive understanding of the analytical procedure and adherence to predefined criteria for performance characteristics. Knowledge gained from application of an enhanced approach to analytical procedure development can provide better assurance of the performance of the procedure, can serve as a basis for the analytical procedure control strategy and can provide an opportunity for more efficient regulatory approaches to related post approval changes.
The guideline also describes submission of analytical procedure development and related lifecycle information in the Common Technical Document (CTD) format (ICH M4Q, The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality – M4Q).