Pharma Companies have a great opportunity to recover lost productivity, as much as $50 Billion every year, with very little changes in the way Cleaning Procedures are managed.
For Pharma, The Future is Now.
LOST ECONOMIC OPPORTUNITY
Based on a data-driven study conducted with ten companies, nearly 14% of the equipment availability is lost directly in carrying out equipment cleaning procedures including subsequent sampling.
An even bigger concern is that this loss is expected to reach nearly 20% in the next 1–2 years due to new regulatory requirements, which now mandate the collection of analytical samples after every product changeover, unless justified otherwise by a robust risk-based QRM.
GROWING REGULATORY CONCERNS
Equipment Cleaning, if not done properly, has a direct impact on patient safety. Hence, it is a critical area of interest to the regulators. This is also true for adjacent regulated industries such as Medical Devices, Nutraceutical, Food, Cosmetics, etc.
As the PharmaceuticalManufacturers scaled its operations to nearly 2x in the last 5 years alone, the supporting compliance procedures did not scale proportionally. More often than not, regulatory agencies (such as FDA, MHRA, etc.) have found critical DataIntegrity issues with the way cross-contamination data is generated and managed.
Since 2016, the number of FDA warnings related to cross-contamination have nearly doubled.
A DEEP DIVE INTO THE BEST EFFORT COMPLIANCE PROGRAMS
Looking deep into the end-to-end lifecycle management program of cross-contamination has some startling discoveries. This is true across departments.
1. Missed Cleaning
The most common issue found is just missing the cleaning due to not having a robust tracking system or failing to establish a periodic monitoring program. Another surprising discovery is failing to establish procedures for dedicated equipment specifically in the facilities where high-risk drugs (such as oncology) are manufactured.
This may sound unreal but nearly all top pharma companies are over-cleaning by as much as 30%. This is due to the lack of a robust risk-based Quality Risk Management Program, which is based on statistical analytical techniques.
3.Lack of Robust Process Design
It is not very uncommon for theAudit Inspectors to find visible residue on the equipment surface despite the companies claiming that procedures were followed. The root cause here mostly directs to the inadequacies in the Cleaning Process Design itself.
There is a serious lack of knowledge base primarily due to the rapid movement of employees across companies, departments, and hierarchies. Also, Pharma is infamous for having an ecosystem where information and knowledge are kept behind large barriers of dollars.
Some have implemented standalone systems that are legacy Record Keeping Systems, work in Silos, have blue-screen user-interfaces and are integrated by hand. This leaves a lot to be desired.
HOW WILL THE FUTURE BE DIFFERENT?
The stage of compliance within most Pharmaceutical manufacturers is still at a stage where critical compliance and quality data is managed using Paper and Spreadsheet. Communication is verbal or email. Essentially, the industry is at the Best Effort Compliance Stage.
TECHNOLOGY IS AVAILABLE TODAY
Today, the stage of technology being used in some of the other industries such as (Automotive, Steel, Oil& Gas, Finance) has reached a level of maturity where PredictiveAnalytics using AI-enabled tools is a commodity. Automated Bots take over everyday tasks such as Compliance. All the relevant data is inter-connected via Integrations of sub-systems. Communication and Data exchange is real time using Notifications & Chat Bots.
No Pharma has fully leveraged it yet.
CLEEN, has the promised to take the industry from Best Effortcurrently to Proactive or Predictive.
THE ROADMAP TO TRANSFORMATION
The key reason why companies fail to achieve outcomes is a misaligned focus on Brands and their buzzwords, and the tools and applications that come with it. The outcome-based approach is missing. The most common ROI calculations done by the legacy players is how much paper will be saved.
Combined with the risk-averse procurement processes of most large pharma, it makes it hard for the truly disruptive technologies to emerge and deliver outcomes.
At the very core, there is a technological disruption that will bring a non-linear change rather than incremental improvements.
This exponential change will need to be accompanied by a robust change management program that is not based on people but rather on process and technology.
At the outset of all this, the delivery of outcomes is the most critical part of any transformative initiatives. This requires benchmarking of existing procedures, establishing mechanisms to measure to progress, hand-hold users to move from a Physical toDigital world and finally quantify outcomes.
As the companies go through the process of adopting technology to disrupt their existing processes, outcomes are seen almost immediately. Some of the outcomes we measure via 2-months studies have the potential to not only de-risk regulatory compliance but also add significant production opportunity.
There are exciting opportunities ahead by combining technologies with strong risk-management tools and robust human-independent processes. Some of the challenges that industry is facing today is spread across R&D, Manufacturing, Packaging, and Marketing, which is managed by multiple stakeholders including Research, Production, Quality, Engineering, Procurement & Sales.
Much like everything else,Compliance is a Journey.
To make this work within an ever-changing regulatory environment, the solutions of tomorrow need to be futuristic, flexible, intelligent and architecturally sound. This requires building capabilities in the areas of Process, Data Science, Technology, Network, and Design.
At Leucine, we are building new-age AI-powered platforms that modernises drug manufacturing Compliance through predictive capabilities of its Compliance engine that scans the entire facility in real time to understand any changes and predict associated risks and provide actionable insights that can reduce the risk of non-compliance by as much as78% and while improving the plant revenue by 2–5%. Leucine is backed by Axilor Ventures (Founded by 2 Infosys Founders), SAP Labs India and USA based Techstars.