The Founding of InstantGMP

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The Founding of InstantGMP

The concept behind InstantGMP started in 2004 when PharmaDirections was engaged to build a manufacturing facility that could be mostly operated with remote staff. The infrastructure for virtual drug development was getting better due to the maturity of the internet and to the increasing availability of tools that allowed groups of workers to access information needed for their jobs remotely. PharmaDirections’ business model was and continues to be based on the capability of virtual employees to work together even though their work places are geographically separated. We decided at the time to use improve on the available tools to create a manufacturing system and quality system that did not rely on permanent staff not did it have to be limited to any one facility.

Our client who needed a GMP manufacturing plant was a non-profit research organization that was planning to conduct Phase 3 clinical trials in third world countries. Their funding came from the Gates Foundation and other philanthropic organizations. When we mapped the manufacturing campaigns needed to support their clinical development plan, the price came to around $6M. We did a return on investment analysis comparing outsourcing the manufacturing to constructing a manufacturing facility and found the cost difference was significant. We estimated a facility dedicated to their product could be built for $1M and the manufacturing conducted in that facility for another $1M. The choice was obvious. The client agreed with the analysis and gave us the go-ahead to construct their plant.

As we planned out the GMP facility and it functions, it was apparent that the facility would be a temporary solution that would not get much use once the initial clinical trial materials were produced. If the clinical trials were successful, the product would be turned over to the World Health Organization for commercial manufacturing and distribution. PharmaDirections suggested that they manage the construction of the facility and the design of the quality system so that all manufacturing information could be accessed remotely. This would allow the client to keep the permanent staff at the facility to a minimum (one or two people) and use virtual staff when manufacturing was needed.

In order to make the quality system work with remote staff, it was designed from the ground up to work in concert with a data base application and a document management system which would be 21 CFR Part 11 compliant. The functionality included specification control, purchase control, receiving, inventory control and electronic batch records. All of the “businesses rules” programmed into the application would be driven by the quality system SOPs which were written at the same time. This system became the foundation of InstantGMP as we know it today.