Auditing Pharmaceutical Manufacturing Compliance Using Generative AI

Automatically check for manufacturing standards violations

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Overview

Pharmaceutical Manufacturing faces a complex regulatory and quality hurdle since there is a pressing need to ensure that manufacturing processes adhere to regulatory frameworks. Frequently, manual analysis of Standard Operating Procedures (SOPs) that govern Manufacturing Protocols is required. This demo shows an automated method to check for manufacturing compliance leveraging the Amazon Bedrock Service. Customers could use similair approaches to deploy automated checking their manufacturing protocols to ensure regulatory or internal quality compliance.

How to use the Demo

Enter a Manufacturing Protocol in the first box and a Standard Operating Procedure (SOP) in the second box. The manufacturing protocol can be a list of instructions or procedures. The Standard Operating Procedure should be a list of specifications that regulate the manufacturing procedure. The Output will be the components of the Manufacturing Protocal that are predicted to violate the Standard Operating Procedure.You can either enter your own text, or select pre-provided samples

How does this demo work?

The demo works by leveraging prompt engineering and an off the shelf LLM from the bedrock service. The model is prompted to read the manufacturing document, the standard operating procedure, and note any violations in an output report.

Architecture

We use Gradio for the front-end app, which is deployed on Amazon Fargate. An Application Load Balancer directs queries to the Amazon Bedrock service, which uses the 3rd party model Anthropic Claude to analyze the documents provided by the user.

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