Article inspired by a Tapas and TECH Talks digital event with insights from customer collaborations.
By leveraging early decisions around process development, quality assurance, and quality control strategies, you can set yourself up for a successful cGMP manufacturing workflow. This article will tackle how to approach process development with a manufacturing workflow mindset that will transition smoothly to cGMP manufacturing.
Understanding robust design
Directed process development means that you focus your efforts on ensuring that your manufacturing process is robust. To understand robust design, you must know the stage of process development when things will start to have a major impact. From a compliance perspective, we have a saying where ‘the process is the product’. So, key decisions early on will impact how you are going to accomplish your goals.
Will you use a manual or functionally closed process?
Will you go with single-use?
Are you using a dedicated equipment train?
Several factors can play in here, and the big three are:
How fast can you get the project going?
How much will this project cost?
How effective will these choices be?
It would be ideal to achieve high speed, low cost, and high quality (Fig 1). Normally, you can only have two out of the three options.
But most importantly, only quality counts. If you do it right the first time, you avoid the time and cost involved in doing it right the second or third time.