To make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration and the maintenance of such registrations.With ICH’s establishment as an international non-profit Association under Swiss law on October 23, 2015, ICH’s mission has been embodied in its Articles of Association as follows: Key to the success of this process is the commitment of the ICH regulators to implement the final Guidelines. Harmonisation is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. Part 2 will consider some of the key new concepts of Q12 in more detail.The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Note that in Europe rework of some local regulations must be performed in order to fully implement some of the concepts of Q12.Ĭlick here to read the Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.
Leveraging Q12 is an excellent way to better explain to regulatory agencies the understanding of greatest risks and the ongoing management of a product through its lifecycle. Structured approach for frequent CMC post-approval changes for commercial products.
PLCM (product lifecycle management) as a key communication tool.PACMP (post-approval change management protocol).ECs (established conditions) and supportive information.Some of the key new concepts introduced are: The extent of this flexibility depends on several factors: (a) amount of product and process understanding, (b) application of QRM (quality risk management) principles, and (c) effective quality system (ICH Q8 (R2), ICH Q9, ICH Q10 and ICH Q11). Moreover, Q12 allows flexibility for post-approval CMC (chemistry, manufacturing, controls) changes based upon the effectiveness of a company’s PQS (pharmaceutical quality system) and risked-based change management system. The FDA is encouraging use of Q12, as it is compatible with their legal framework. Q12 is focused on the commercial phase of the lifecycle of a drug substance, drug product, and drug-device combination product. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.Ĭhange is a natural occurrence over lifecycle due to evolving knowledge, improved understanding about processes and systems, and efforts on continuous improvement.
ICH (International Council for Harmonization) recently adopted () the guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The Latest on Regulations: ICH Guideline to Manage Change throughout the Commercial Lifecycle of Drugs and Combination Products – Part 1
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