Put “Spring Cleaning” on Your Summer Compliance To-Do List


Summer can be the time of laid back, restful behavior, but it is also a perfect time to assess your half-year of progress and clean up what needs to be done for the remainder of 2015. While housekeeping can be a chore, breaking the tasks into small steps done on a regular basis can keep you on top of your cleaning game. With ever-closer FDA scrutiny and new guidelines in effect, the cost of drug development has never been higher. According to a recent study by the Tufts Center for the Study of Drug Development, the cost of new prescription medication development through market approval is $2.6 billion. Contract manufacturing organizations (CMO) can polish their activities in the following compliance areas to make sure they pass that white-glove test and keep costs to a minimum:

  • Plan for multiple batches. Historically, one batch of active ingredients was all that was needed for an FDA registration application; increasingly that is no longer the case. Incorporate into your timeline two or three additional batches to meet registration stability requirements. Generally speaking, the overall quality of the batches should mimic the quality of the production-grade material. This adds costs on both the customer’s end as well as the CMO’s, but sweeping multiple batches into your projects from the get-go can save you time, money and aggravation down the road.
  • Ramp up your own quality scrutiny. Do you need to dust off your analytics? Are you applying the right level of expertise? Are you investigating thoroughly enough? The FDA’s watchful eye provides a laser focus on quality, so make sure you are doing the same, and building analytics earlier in the process. While the proposed 21st Century Cures legislation – which would overhaul federal regulation and approval of prescription drugs as well as provide significant new funding for innovation and federal research — winds its way through Congress, applying tough analytical scrutiny at every stage will lead to safer medicines for everyone. The overall scope of work for products going through clinical trials hasn’t changed, but the FDA is now asking quality/analytics questions earlier in the cycle. Applying analytics from the project’s start will reduce technical risks; if you are already well underway, apply those analytics moving forward.
  • Be more selective with customers. It is time to pay more attention to the company you keep. Drug development is dynamic and continuously evolving, and your customers need to be 100 percent committed to seeing it through. Make sure you understand your customers’ business model and that they understand what needs to be done under the current FDA guidelines. Do they have the appetite for investment, both in time and money? Just 30 percent of drugs make it to phase 1 clinical trials, so your customers need to have the right level of stamina and a good business model. Build all the requirements into your proposal so that expectations and deliverables are documented. Check in regularly to ensure you are meeting all deliverables and requirements. The last thing you want is to be one year into your relationship and discover it isn’t working.

These simple steps can go a long way towards keeping your CMO business in tip-top shape.