GAMP4-Compliant Software to Automate Cancer and TPN Drug Manufacturing

Summary

A large multinational pharmaceutical company needed to replace an outdated, non-scalable system for ordering and manufacturing short-living chemotherapy and total parenteral nutrition (TPN) drugs. INNERLUXES delivered a GAMP4-compliant, full-cycle .NET solution spanning data maintenance, production, stock control, invoicing, reporting and security — a system the company and its clinical clients have now relied on for more than ten years.

About the Client

The Client is a large multinational pharmaceutical company that develops and supplies lifesaving oncology and other critical-care medications to hospitals, clinics, assisted living facilities and patients' homes.

An Outdated, Non-Scalable System Holding Back Drug Manufacturing

The Client needed a centralized solution to cover the production of generic and non-generic short-living chemotherapy drugs and TPN (such as cyclophosphamide, 5-FU and cisplatin), along with stock control, client information and financial transactions for direct sales. The solution had to run not only at the Client's own sites but also at its medical customers' facilities.

The previous system was outdated, unreliable and costly to maintain. It split the "dispensing pharmacy" and "total parenteral nutrition" functions into two separate modules that had to be supported and updated manually, and it could not scale to support the Client's growth. Ordering still relied on dated media such as fax and phone, and the system did not comply with the latest GAMP4 standards.

The Client therefore asked for the system to be rebuilt as a scalable, easily updatable platform that would align the separate modules and add the missing ordering, invoicing and reporting capabilities — a full-cycle system able to safeguard the manufacture of first-line oncology drugs and TPN medications.

A GAMP4-Compliant Full-Cycle .NET Platform

INNERLUXES implemented the new integrated system on the .NET platform, with the server application and client applications interacting through .NET web services. The solution is organized into the following modules:

• Data maintenance. A central database stores the system's objects — hospitals, patients, orders, batches, order statuses and more.
• Production. Covers the full manufacturing process: drug order and recipe entry, entry review, pre-compounding, compounding, post-compounding, labeling, release and delivery.
• Stock control. Lets the Client's specialists oversee product flow, monitor component inventory and restock in time to keep production uninterrupted.
• Invoicing. Tracks the full procurement process, with new invoice creation and search by client, project, status or creation date, plus quick filtering for outstanding, overdue and paid invoices.
• Reporting. Generates reports by KPI, orders, hospital clients, stock, expenditure and other factors, with charts, metrics and trend overviews for in-depth operational and financial analysis.
• Security. Safeguards and authorizes every important step — beyond login-password authorization, each manufacturing step requires the user's PIN.

To illustrate how the production module works: with the system installed at a hospital's dispensing unit, a physician prescribes an oncology drug for a specific patient, and the physician or pharmacist enters the order and routes it to the factory nearest their location. The factory's software then automatically validates the recipe, dose and components, and can plan production for an entire course of treatment from a single order — calculating the number of doses for, say, a six-week course and scheduling each dose's preparation and delivery.

At the pre-compounding stage, the system selects the right components according to a "least waste" policy and prints instructions on the required components and mixing techniques for the dispensing-isolator technician. Post-compounding adds a further validity check, and at the labeling, release and delivery stage each medicine is labeled with the patient's name, location, shelf-life date and storage requirements before being handed to a courier for delivery.

A System Trusted in Production for Over a Decade

INNERLUXES delivered a GAMP4-compliant, full-cycle solution that automates the ordering and manufacturing of generic and non-generic short-living chemotherapy and TPN drugs in support of better chronic disease management. The solution brings together the data maintenance, production, stock control, invoicing, reporting and security modules, and its client-server architecture lets hospitals and other clinical clients request medicines from the factory closest to them through the client application.

• A single GAMP4-compliant platform replaced the outdated, non-scalable two-module system.
• The Client and its end clients have been using the delivered system for more than ten years.

Technologies and Tools

Technologies: .NET Framework, ADO.NET, ASP.NET, AJAX, VB.NET, JavaScript, Infragistics, Citrix Server API, Crystal Reports.

Development processes: ISO-9001, GAMP4.