2020 was an insightful and impactful year for the biopharma industry, offering a look into the industry’s preparedness for unpredicted events, but also at the shortcomings and challenges ahead.
To help you keep up with the changing landscape in the biopharma market, our team of experts have shared three major considerations the industry should pay attention to when planning for greenfield or brownfield projects.
3 Ways to Prepare for Changes in Biopharma Manufacturing
Biopharma companies should be prepared to expect the unexpected by building in contingency plans around the following:
1. Anticipate Supply Changes
Regardless of industry, we all feel the pains of interruption across the global supply chain. By having a contingency plan in place while anticipating what potential factors could interrupt your supplies, you can reduce the potential of having your projects go off-track.
One of the most important things you should consider is working with qualified and responsive vendors. While that may seem like an obvious piece of advice, securing trusted, reliable, and sometimes redundant supply partnerships early on can save you many headaches.
2. Secure the Right Talent
It’s an employee’s market right now, and having skilled, well-paid, and well-cared-for staff on your projects is the ultimate advantage. You could have all your boxes checked when it comes to your facility and equipment, but if you don’t have the right talent, you won’t get very far.
As crucial as it is to have the top technicians and scientists on your team, don’t overlook securing the right commissioning and qualification services experts, too. The right CQV team keeps your projects on track and can anticipate and negate potential risks.
3. Don’t Neglect Regulation Changes
Regulatory compliance is a constantly moving target that can be hard to hit. With the FDA leveraging emergency use authorization more than ever before, it’s important to maintain FDA inspection readiness and stay on top of other regulatory bodies’ guidance as your projects evolve.
When our Boston-area client retrofitted an existing facility to fill an immediate need for COVID-19 diagnostic testing for our nation’s teachers and students, they recognized an immediate need to bring in ICQ’s experienced validation engineers. Our engineers were able to swiftly validate their new equipment and software while building a foundation for Good Manufacturing Practices.
Read the full story: Fast Action Gets Covid-19 Testing Lab Ready for National Work
Planning Ahead and Expecting the Unexpected
While we may not always know what lies ahead, our industry has proven its ability to pivot during a crisis. By continuing to share best practices with each other and working with the brightest leaders in the industry, we can ensure access to life-saving products for those in need.
If you’re getting ready to start a new project or have one underway, our CQV experts are ready to help keep your timeline and budget on track.