Smart Quality Control in Pharma
(6 minute read)
Over the next decade, new technologies that characterise Industry 4.0 such as advanced analytics and connectivity, robotics, and automation, have the power to transform pharma quality control labs. This blog looks at how.
Technology is expected to revolutionise all aspects of pharma quality control from rapid development and manufacturing to boosting productivity and quality standards. Digitisation and automation can also ensure better quality and compliance standards, minimise error and risks, and reduce testing times for rapid product releases.
This is not without its challenges though as upfront investment costs, misaligned business objectives, lack of clarity around innovation strategies, and poor organisational vision can hamper the implementation of technology.
Three Horizons of Lab Evolution
As more digital and automation technologies get embedded into pharma, the evolution of the smart lab is expected to evolve over three types of horizons. These are not mutually exclusive and the three variations may have compounding effects on one another.
Horizon 1: Digital Labs
This lab will transition from manual to automatic data transcription and verification into a Lab Information Management System (LIMS) which will also be extended to data sharing with internal and external suppliers. These labs will use real-time data analytics for ongoing process verification, optimising scheduling, capacity management etc. Tools such as smart glasses for standard operating procedures and digital twins for impact prediction will also become more widespread, resulting in significant cost and deviation reductions.
Horizon 2: Automated Labs
This lab will see greater use of robots and other advanced automation technologies for performing repetitive tasks like sample delivery and preparation. High-volume testing will be done online. Automation will also feature in predictive maintenance technologies for maintenance of large equipment, performed with remote support. Automated labs will build on features of digital labs to deliver greater cost savings, time reductions, improvement in productivity and logistics, and reduction in overall lab lead time. Many health and research labs already have technologies and next-gen analytics that are readily adaptable to pharma. Emergent methods in advanced analytics, general and collaborative robotics, and lab-automation technology will enhance the effectiveness of these labs even further.
Horizon 3: Distributed Quality Control
This represents a true disruption of traditional quality control methods where nearly all routine product testing takes place on the production line, allowing for real-time release testing (RTRT). At this level, testing takes place on- or off-site using AI-enabled equipment and robots. DQC facilities reduce physical footprints and costs and accelerate product releases but may require significant R&D investments and a compelling business case. Relevant technologies can be pulled in from adjacent spaces such as platforms offering advanced process control, automation, and other smart solutions to quality management.
Key Success Factors
Some key success factors are essential in implementing smart quality control approaches even while pharma companies are working on traditional methods. Five key challenges faced by pharma include:
- Clearly articulating a cross-functional vision for how tech enabled smart solutions will transform their core quality control business
- Defining a compelling business case for the R&D cost and tech investments required to realise this vision
- Scaling up with an agile approach to design, testing, pilot, and iteration
- Formulating a technology plan for the kind of tools and approaches that will allow the lab to evolve over the horizons
- Facilitate the requisite change management capabilities needed for the transformation
With the right mix of mindset, technologies, and organisational capabilities, pharma companies can transform the way they perform quality control.
