Electronic Batch Records: From 4-Page Documents to 150 Pages, and What Comes After Digitisation
Pharmaceutical manufacturing veteran Shirish G Belapure on the four-decade evolution of batch records, why tablet-making technology is unchanged while documentation has exploded, and where the industry sits on the path to lights-out manufacturing.
Vivek Gera Host
Co-founder · Leucine
Shirish G Belapure
Pharmaceutical Manufacturing Expert · Pharmaceutical Industry
About this episode
Vivek Gera speaks with Shirish G Belapure, a pharmaceutical manufacturing expert with 46 years of industry experience, about the extraordinary journey of batch documentation — from four-page records in the 1970s to 150-page documents today — and what that evolution reveals about where manufacturing technology actually is versus where it is assumed to be. Belapure makes a counterintuitive observation: while batch records have grown tenfold, the core technology of making tablets has not fundamentally changed. The real evolution is happening in the intelligence layer — instruments on manufacturing lines, NIR and Raman spectrophotometers, cameras for active ingredient verification — and pharma sits somewhere between the second and third level of a five-stage digitisation hierarchy, with lighthouse plants just beginning to emerge at companies like Cipla and Dr. Reddy's.
Topics
Key takeaways
- Batch records have grown from 4 pages in the 1970s to 80–150 pages per batch today — not because manufacturing changed, but because regulatory depth and process documentation requirements have compounded over four decades
- The technology of making tablets has not fundamentally changed: basic equipment, basic process, basic formulation logic — what has changed is the intelligence and instrumentation layer on top of the same core operation
- Pharma sits at the second or third level of a five-stage digitisation hierarchy: instruments are now on manufacturing lines, but AI-driven batch decision-making — where a machine decides batch disposition instead of a technician — is the next level most companies have not reached
- Lighthouse plants are just beginning to emerge in India at companies like Cipla and Dr. Reddy's; the next aspiration is lights-out manufacturing where operations can be managed remotely, but that is still a significant distance away for most
- Continuous manufacturing has not scaled in India despite regulatory acceptance partly because most Indian facilities are multipurpose — designed to run many products — while continuous manufacturing economics work best for single-product, high-volume lines
- Hand holding and the stick are both required to drive industry-wide compliance improvement — neither regulatory pressure alone nor support alone has moved the needle; the combination is what drives lasting change
Continue exploring
Powered by
Leucine MES
See how automated documentation eliminates the gaps that cause FDA 483 observations.
See Leucine MESSee how Leucine's AI-native platform is transforming pharmaceutical quality and manufacturing operations.
