Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The new guideline ICH Q12 and its application to the production transfer of European approved and approvable medicinal products to a new manufacturing site - Does it provide any new benefits for the regulatory strategy? ***

Dr. Daniela Matthey-Inführ (Abschlußjahr: 2020)

Summary
Language: English
The mission of the ICH is to increase the harmonisation of regulatory approaches worldwide to improve the development and manufacturing of medicinal products to ensure they are of constant high quality as well as safe and effective for the patient.
So far, quality guidelines of the ICH have not particularly considered the drug product's lifecycle after approval. Although in the past, with the implementation of design space and quality by design (according to ICH Q8 – Pharmaceutical Development), a good basis to increase the scientific and process-related knowledge of a product has been established. Together with the principles of quality risk management provided by guideline ICH Q9 and the implementation of a pharmaceutical quality system as described in guideline ICH Q10, risk-based knowledge of the product is achieved and innovation and continual improvement is facilitated by monitoring of process performance and product quality.
With one of the newest guidelines – ICH Q12 (with the title: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) – the current guidelines ICH Q8 to Q10 (and Q11 for development and manufacture of drug substances) are now complemented to cover also the period of a product's lifecycle after approval. It introduces tools and enablers to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes in a more predictable and efficient manner.
The draft of ICH Q12 was published for public consultation in November 2017 and more than 900 comments from industry and associations were received until December 2018, showing that there was an enormous interest worldwide to get the most out of the approach of harmonising a product's lifecycle. The guideline was amended in 2019 and adopted on 20 November 2019 (Step 4).
Though the guideline ICH Q12 tends to harmonise technical and regulatory tools for pharmaceutical product lifecycle management throughout the regions that are accepting ICH principles, it is clearly stated in several chapters of the guideline that regional guidance and requirements may be considered. The responsibility to provide publicly available information about regulatory considerations to be assumed for the implementation of ICH Q12 in a specific region lies with the regulatory members of the ICH region.
The present master thesis deals with a real scenario of a planned manufacturing site change for drug products and how the product transfer can be accomplished in a resource-conservative way. The use of a post-approval change management protocol (PACMP) is described as an example. The advantages and disadvantages of a PACMP for European approved and approvable products are compared to those of the "classic" way of submitting post-approval variations according to the Classification Guidelines and the Variations Regulation.
This tool has already been established in the European legislation with the former version of the European Commission (EC) Classification Guidelines (2010/C 17/01) that supported the Variations Regulation (Commission Regulation (EC) 1234/2008). The Expert Working Group responsible for the compilation of ICH Q12 expects that the application of PACMPs will continue to increase with the implementation of the guideline in the EU/EAA due to global harmonisation and international recognition by the authorities. Consequently, more Type IA and Type IB variations will be submitted instead of Type II variations. Problems with drug shortages could be reduced and manufacturing efficiency and innovation increased.
Page: 57 Annex: 1, Pages: 4