How to successfully implement a new process

It is always exciting to develop a new cell therapy product, and finally be able to meet a demand of patients and physicians alike. But implementation of the new process is so critical phase that supervisors are usually tasked with. If not done correctly, implementing a new process can result in: 

• Failure of production runs
• Loss of cell product
• Hold of study (at advanced stages)

Process implementation is the activities/actions that result in preparing a production facility for production of a new product; basically, ensuring the production facility is ready at all levels.

To make the implementation a success, as a supervisor you need to ensure all components of production are ready. To do this, you will do the following on every component:

1. Assess: Review the current status of a component with regard to the new process, identify the gap, and define the fix.
2. Fix: Assign one of your team to fix the gap you identified to make the component ready for the new process.
3. Check & Approve: Once the gap fix is completed, review the fix to ensure its compliance, and move for approval. Once you have identified and fixed the gaps, and approved the changes, you may move to the next steps:
4. Take one step back: Look at the big picture by examining the entire production system to ensure it is streamlined.
5. Test: Run an experimental study (pilot study) that puts all components into action, and use all approved components.
6. Re-assess: Review the data of the pilot study and look for deficiencies. If all are satisfactory then you can conclude the implementation activity. If you identify a new gap, start over.

This implementation system should prepare your production components for clinical production, but what components need to prepared?

The specifics of this vary by product nature and production process, but generally, the following components should be part of every new product:

A. Documents: Ensure all documents support the new product process. Among others, this includes product receipt, material specification, production records, and certificate of analysis.

B. Facility: If the facility need to be modified in any way to adopt the new process, ensure the modification-related re-validation/re-qualification activity, if any, is completed.

C. Personnel: Often, new processes involve new techniques that require some type of training. Ensure all training is successfully completed and documented.

D. Equipment: Ensure new equipment installation, operation, and performance qualification is completed, and any periodic maintenance is performed. Additionally, ensure the equipment are capable of handling the new product or its samples.

E. Material: Most new products come with a list of new material, ensure you have received the new stock, and is approved for use.

There is one more component that involve the Collection Facility and the Clinic. Make sure the details of how the new product is collected and sent to your facility is worked out. Similarly, make sure the details of distributing the new product to the clinic are considered.

Careful preparation to implement new product pays off down the road. Errors are still expected to occur, but with good preparation, most of the major errors would be prevented.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us. 

About the author

Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here