In this download, we break down the various areas often requiring attention and corresponding considerations for a successful GxP commercial launch. Read an excerpt below or download the free eBook to view the entire piece.
Clinical companies face significant challenges as they approach regulatory approval and commercialization of their first product(s). Behind many of these challenges is the reality that being successful in clinical operations is quite different from being successful in manufacturing operations. At a strategic level, major differences include required skillsets of personnel, regulatory environment, operating culture, and facility requirements. At a tactical level, the differences explode into a complex array of challenges often intensified by the looming reality of the scheduled Pre-Approval Inspection (PAI) date. These challenges arise whether the clinical company plans to produce the commercial product itself or employ a Contract Manufacturing Organization (CMO) for production.
One common situation faced by emerging pharmaceutical or biotech companies transitioning from clinical to commercial is successfully completing all of the necessary activities in the required timeframe. This challenge is often exacerbated by the reality that:
- All of the required processes across the entire quality and supply chain systems need to be defined, developed, and instituted.
- All of the supporting documents (Policies, SOPs, Work Instructions, Forms, etc.) need to be authored, edited, approved, and made effective.
- Applicable training for all processes, procedures, and practices needs to be developed and delivered.
- Managing substantial culture change needs to occur and be complete and effective.
- Supporting software (e.g., QMS, document management, LIMS, MES, etc.) requirements need to be defined, the software vendors selected, and the software purchased, configured, and implemented.
- Suppliers need to be identified and qualified, and corresponding contracts need to be negotiated and finalized.
- Ongoing selection and hiring of required personnel to support the quality and supply chain functions needs to occur. Once hired, their assimilation and learning curves consume additional time.
Many of these activities require a large initial investment of time, resources, and expertise followed by much smaller resource requirements for ongoing operations. All too often, emerging companies underestimate the full scope of activities and the time required for successful development and execution of all necessary systems. Coupled with the fact that these companies are simultaneously hiring the staff needed to develop and implement all of the elements needed for the PAI, the result is often a chaotic attempt to meet what becomes an impossible deadline. PAI postponement and/or PAI failure become inevitable. Both of these undesirable outcomes can be avoided.
Ensuring a Successful GxP Commercial Launch
At Clarkston, our consultants have the expertise and experience to assist in developing and implementing efficient, compliant processes; overcoming the mountain of initial work; training new and existing staff; and managing the changes and timelines necessary to successfully navigate the PAI and transition into commercial manufacturing. Our team provides the full spectrum of GxP support from a comprehensive development and implementation of all GxP processes to simple assistance through the authoring of a few SOPs to help prepare for the PAI and commercial success beyond. For assistance in developing or remediating GxP processes, reach out to our GxP compliance experts.