ICH Q8 R2 are international guidelines for ensuring Quality by Design in pharmaceutical development. Here’s why a QbD control strategy should be driving your company’s drug development process.
The ICH has developed tripartite guidelines for the quality and risk management of the pharmaceutical development and manufacturing process. These mutually supportive guidelines, ICH 8, ICH 9 and ICH 10, cover how pharma companies should:
The ICH Q8 Pharmaceutical Development guidelines are a comprehensive framework for using QbD (Quality by Design) principles to ensure a systematic, process-driven approach to drug development.
QbD involves designing quality into the product through effective planning and management of each development and manufacturing stage. This marks a shift away from using a traditional, experimental approach to pharma development and QC testing. Instead, QbD looks to develop a more dynamic, comprehensive quality assurance (QA) methodology that ‘bakes quality’ into the product from its inception.
ICH quality guidelines are not mandatory for developers but are increasingly being embraced to control the wasted time, resources and inconsistent results that have been endemic in the pharma space.
Research suggests ineffective and inconsistent quality management is increasing the overall cost of pharmaceutical development and fuelling escalating drug prices.
According to research published by the LSE in 2020, the median cost of bringing a new drug to market was estimated to be $985 million, while the average cost was $1.3 billion
(source LSE)
Testing failures, inefficiencies in preclinical experiments, issues with monitoring and maintaining manufacturing standards all contribute to high levels of abandoned projects, failed audits, and product recalls.
Indeed, in 2022, drug recalls reached a five-year high while the aggregated cost of quality failures in the global industry ran into billions.
The ICH Q8 guidelines help developers ensure they adequately define a product profile before they begin their development process. It asks them to identify a product’s critical quality attributes (CQAs) and then show how they will select raw materials, create SOPs and control Critical Process Parameters (CPPs) to deliver designs that consistently meet quality demands.
Linking and animating all these elements is the ‘control strategy’ - the combination of process and data-driven decision-making that results in validated drug designs and manufactured products that are safe and efficacious.
Here’s how these elements work together to ‘bake in’ quality to your end products from the start:
At the heart of QbD lies the documentation of every aspect of pharmaceutical development, from the definition of the Quality Target Product Profile (QTPP) to the regulatory submission of your proposed design space and the management of the design-to-manufacture process.
Documentation supports and evidences all your decision-making, creating records of approval, change control, deviation management, and process validation. It proves to regulators and auditors your product has been designed and manufactured exactly as you have specified - minimising the risk of failure in every part of the cycle.
But in a sector where developers generate so much complex data and documentation, it’s impossible to organise it all manually. You need to ensure that all the documents you create are being indexed and controlled as they are created - automatically generating the complete audit trails you need to share with regulators like the FDA.
The integration of digital technologies to control your process and documentation should help you derisk and accelerate every part of your drug development process, making each project more transparent and auditable.
Store quality records and documents safely and prevent them from loss or fabrication.
Create workflows to ensure design and quality documents are subject to required reviews and approvals.
Create document holders to ensure required groups of documents can be collated and reviewed together by specific stakeholders - before the next stage of a process is triggered.
Impose change controls to ensure key processes and documentation are never changed without permission.
Deviation management - showing how you investigate non-conformances and trigger CAPA processes.
Handle Process Analytical Technology (PAT) and advanced data analytics with mechanisms for real-time monitoring and control of manufacturing processes.
Instigate automatic process review to fuel continual improvement efforts across your product development lifecycle.
The ICH Q8 guidelines have been pivotal in promoting the Quality by Design approach within the pharmaceutical industry. As companies increasingly adopt these principles, we can expect a future where drug development is not just about meeting regulatory standards but about exceeding them.
For scaling drug development companies, the challenge is finding the QMS tools that can help them marshal and automate their process and documentation - without imprisoning them within the expensive and inflexible software packages deployed by the pharma giants.