Pharmaceutical Manufacturing Analytics - Succeeding in Regulated Environments

Do you have any idea of the descriptive and predictive analytics that went into that pill you took this morning? Do you know how pharmaceutical manufacturing analytics are at work in vitamins you took or the skin cream you rubbed on?


Quite a bit, it turns out.

Any company engaged in pharmaceutical development or pharmaceutical manufacturing generates a great deal of data on production, most of it aimed at answering the question, “Are we ready to ship this yet?” Regulators, auditors and customers also want to see data to answer the similar questions, “Were you really ready to ship this yet?” or “Did the facility making the product follow cGMP?”

Thus, pharmaceutical and biopharmaceutical companies are almost as much in the data business as they are in the drug business. Data has led them into the world of pharmaceutical manufacturing analytics, where production, quality and supply chain data is at the heart of most of the answers. The right predictive analytics platform can help them not only improve efficiency and quality but also meet regulatory requirements, ensure product safety and more.

Predictive analytics for pharmaceutical manufacturing

This is a long way from the land of spreadsheets. The pharmaceutical manufacturing that goes into a single lot can involve gigabytes of data and thousands of variables. Tracking that in a spreadsheet – let alone performing analytics on it – would be an exercise in using the wrong tool for the wrong job.

Predictive analytics in pharmaceutical manufacturing relies on several high-end capabilities worth looking for in a software platform:

  • Multivariate statistical process control
  • Quality control and root cause analytics
  • Monitoring and alerting
  • Real-time processing
  • Double-blind validated data entry
  • Support for future-oriented use cases like predictive/preventive maintenance, warranty analytics and demand forecasting
  • Modules for product traceability, product stability and shelf life analysis

Paper: Analytics Platforms in Regulated Manufacturing

I’ve written a paper called Key Considerations for Analytics Platforms in Regulated Manufacturing. Read it for a close look at what makes regulated manufacturing environments like pharmaceuticals different when it comes to predictive analytics. It includes an overview of the standards to which pharmaceutical manufacturing must comply and suggests a comprehensive, validated predictive analytics platform that ensures regulatory compliance, promotes best practices, and helps to ensure product quality and safety.