For late-stage biotech and biopharma organizations, ensuring GxP commercial launch readiness is critical to achieving success, and there are key strategies and business decisions you will need to make that set the groundwork for your commercial launch.  

As a company prepares to move from clinical to commercial operations, quality leaders will need to evolve their approach and leverage their knowledge to develop and implement efficient, compliant GxP processes to scale up for commercial success. In addition to updating systems and processes, it is also critical to prepare the organization for the upcoming changes. There are many critical factors that are sometimes overlooked, which may be cited by regulators during review. Several of the key areas to be considered include process scaleup, documentation, training, systems technology, quality culture, and Organizational Change Management (OCM). Let’s look at these in detail: 

Ensuring GxP Commercial Launch Readiness

Process Scaleup

As you move into the commercial stage, the production processes used for clinical trial materials will need to scale up to handle the increased quantity of products needed for the expansion into the commercial market. Your tech transfer team will be responsible for the engineering design and validation of scaled-up processes, and the quality system must scale up to handle the increased workload as well. As you are producing more product for the commercial state, all related activities will increase as well – more incoming material inspections, more lab testing, more batch release review, and so on.  Any missing systems or processes will need to be developed, and any substandard systems or processes will need to be updated and remediated. 

Documentation

Documentation of processes and procedures must be in place. As is often said, “If it wasn’t documented, it wasn’t done!”  As you move to commercial operations, you will need to prepare for regulatory inspection and review. Processes need to be documented in approved procedures, and you must have evidence of testing to show that the procedures you are working on are valid. The documentation of manufacturing, testing, and training provide the evidence that activities have been performed in accordance with approved procedures and that people are properly trained to perform their work.  

Training

Training is another critical area that must be established as you move into commercial production. You will be hiring as you scale up production, and it is key to ensure that all new hires are properly trained in basic GxP requirements and documentation, well as in the process areas in which they will be working. It is so important that as people’s jobs expand, they are properly trained to take on all new responsibilities as the company grows.  Training curricula and courses must be established and assigned, trainers must be qualified, training results must be documented, and effectiveness of training must be evaluated. Additionally, as new electronic systems are implemented, you have to plan for the time needed for training new users and making sure the requirements and processes used for any new systems are understood.  

System Technology  

As the company moves into commercial production, the technology used to manage various processes will most likely need to be upgraded and expanded as well. Before commercialization, smaller companies can often use SharePoint files and Excel spreadsheets to manage the documentation requirements for their systems. As a commercial company, you will need validated, controlled-access enterprise systems to address the increased volume of records that will be generated.  

One of the most important systems will be your Quality Management System (QMS).  The QMS includes requirements for systems to manage things such as documentation, deviations management, CAPAs, complaints, and change management. You will also need systems in place to meet requirements for Enterprise Resource Planning (ERP), vendor management, Laboratory Information Management Systems (LIMS), regulatory filings and submissions, and audit management. 

Quality Culture 

A Quality Culture change may be needed to ensure that the company is operating with a GxP quality mindset instead of a compliance mindset. In a compliance mindset, there is often a focus on adherence to rules, regulations, and standards as a means to ensure legal conformity and avoid penalties. It prioritizes meeting regulatory requirements and often emphasizes process over outcome.  ​

Alternatively, a shift from a compliance mindset to a quality mindset moves beyond the focus of simply meeting regulatory requirements to focusing on consistently delivering high-quality products through the promotion of continuous improvement, accountability, ethical decision-making, and the idea that quality is everyone’s responsibility. ​ 

Organizational Change Management 

Along with updating systems and processes, another key factor for preparing for commercial launch is change management. It is important to start this process early to ensure that the people who are going to be impacted are well aware of the upcoming changes and the reasons for these changes. There will be many new ways of working, and changes in roles and responsibilities. New systems are being implemented, and new requirements may be adopted. Relationships among departments and division of labor (who does what) will also change as the company grows into commercialization.  

Some of the best practices in preparing your organization for change are to define the goals early and communicate frequently and widely about the plans for change.  Having a good project management office (PMO) oversee all the commercialization initiatives and to develop the change plan with clear goals, milestones, and a corresponding communication plan will be key.  This will help people know when the proposed changes are coming and can help them prepare themselves for the transitions.  

People need to be kept informed about how they personally will be impacted by the changes, as everyone wonders “What’s in this for me?”  People will also need to know what the company will start, stop, and continue doing, and the reasons why these changes are being made. A good communication project plan to keep everyone informed of all the changes can help ease the transition and encourage the adoption of new values, attitudes, and behaviors.  

The journey raises many questions. 

The journey to commercialization requires many important decisions. You must understand your current capabilities as well as what is required to support the business as you move toward commercialization. Having well-identified milestones and stage gates allows tracking of progress and continual assessment of existing gaps, and the impact on your people, processes, and technology required for successful commercialization.  

Clarkston Consulting has compliance experts  with the experience and successful track record to partner with you during your commercialization journey. We also have significant experience in helping companies navigate organizational changes, so please reach out to us for more information.  

Contributions from Josh Edwards