When PharmaDirections undertook a project to design and build a GMP manufacturing facility that would become a site for InstantGMP™ production, one of the key considerations was designing a virtual quality system. The requirements were to have policies, procedures, documentation and training that could be paperless and could be accessed remotely through the internet. We used a Quality by Design approach to achieve these goals.
There are many ways to assure GMP compliance with a quality system. The traditional approach is to write Standard Operating Procedures (SOPs) to describe each of the operations in a manufacturing facility. This is usually a time consuming project that requires individual authors to commit part of their time to these activities in addition to their normal duties. The advantage is the SOPs are very specific to the site where GMP compliance is needed. Another approach is to purchase a standard set of SOPs and then tailor them to the unique requirements of the site. In either way, the SOPs are usually paper based. Our approach was to design a quality system that would be virtual and paperless and thus not be limited to a single site.
We used a team approach where we gathered experts in manufacturing, quality, inventory control, database programming and project management to catalog the requirements and risks of producing regulated products where documentation management and control of the product could be done with remote access. We planned to limit the time on site to just the activities needed for warehousing and manufacturing. All other activities would be available to staff who did not need to be on site to perform their duties.
To write our virtual quality system, we used Quality by Design principles. The FDA promotes this concept for manufacturing where they expect quality can be designed into the process after gathering all the knowledge obtained during product and process development and after understanding the risks and determining how these risks can be managed. We applied the same concepts for the Instant GMP quality system. The requirements included being paperless, being 21 CFR Part 11 compliant, accessible via the web and being integrated into a data base application. The intent was to use the Instant GMP data base application to control the manufacturing process in a way that the SOPs would automatically be followed. After six months of coordinated design and computer programming we delivered a beta test system to the first manufacturing site.