DIGITISING CLEANING PROCEDURES: A $50 BILLION OPPORTUNITY

Vivek Gera
Jul 3 · 5 min read

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

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

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

1. Missed Cleaning

2.Over Cleaning

3.Lack of Robust Process Design‍

4.Knowledge Gaps

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?

TECHNOLOGY IS AVAILABLE TODAY

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

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.

IMMEDIATE OUTCOMES

ROADMAP AHEAD

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.

leucine

Bringing Efficiency To Pharma Compliance

Vivek Gera

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leucine

Bringing Efficiency To Pharma Compliance