Masterarbeit

Introduction of the ICH Q12 (Draft) Guideline: An approach to a proactive evolution of a product- Chances, risks and practicability ***

Rosi Puniyani (2018)

Summary
Language: English
Since its foundation almost 30 years ago, the ICH has committed to the harmonization of regulatory standards and requirements in the pharmaceutical industry. In particular, in the area of medicines quality, an extensive range of guidelines has been developed by the ICH in the last few years to provide guidance on the GMP-relevant aspects of the product and process development in the pharmaceutical industry. The newly proposed Q12 guideline, which is still in draft form, now completes the series of the quality guidelines, and aims to look beyond the early pharmaceutical development stage covered by the long-established Q8-Q11. The guideline focuses on the maintenance of quality during the commercial manufacturing phase that is across the entire life cycle of the product.
The expectations towards this guideline both from the regulator and the industry perspective are high. The potential benefits range from the reduction of costs and time burdens for the regulators and the industry, while ensuring that patients have timely and reliable access to the necessary medicines, to the increased transparency in the regulatory environment and the enhanced harmonisation both within and potentially also outside the ICH regions. Properly implemented, it should encourage better product and process understanding and continuous improvement during the entire lifecycle of the pharmaceutical products.
However, despite the obvious advantages, the guideline also holds challenges and sparks controversies.
As with the harmonisation efforts, the guideline is intended to meet the needs and to respond to the requirements of the pharmaceutical product lifecycle at many various levels. These include the special characteristics of chemical drugs relative to biologics or biosimilars, with their respective differences in the manufacturing approaches, the diverse needs of small and large companies, as well as the distinct requirements of development and already marketed products. Experts raise concerns if the guideline in its current form will be able to meet the high flexibility required by its defined objectives.
In order for all parties to be able to fully benefit from the newly developed guideline, common understanding of the guideline principles will have to be established and their realisation has to be tried and proven in practice. In some cases, existing regulations and guidelines will have to be revised at regional level to ensure successful guideline implementation.
All these considerations will take time to develop and to manifest. In the meantime, the ICH Q12 guideline is now undergoing a period of public consultation, which will last one year after its introduction in December 2017. It remains to be seen, how, to what extent and how quickly the guideline will change the regulatory practice of the post-approval CMC across the product lifecycle.
Pages: 40, Annex 1: pages: 5