What Considerations Should Be Made When Planning A Feasibility Study?

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WS-12-2013_28When developing a drug product, feasibility studies are significant in fine-tuning your processes from the formulation stage to the final production stages. These studies give opportunity to confront potential process variables for either new products or existing. Overall, mapping out a feasibility plan can improve inefficiencies in the process and equipment train. To start, clear objectives of the project must be clearly identified, and from there, a series of experiments must be put into place to test out what pre-existing issues may be present. In the absence of potential issues, it should identify the critical processing factors that coalesce to consistently manufacture and reproduce a quality product.

Here Are Some Key Ways To Approach Your Feasibility Study Plan

Manufacturing Processes Guide Feasibility plans will not always take on the same form or shape for each project – there will always be unique strategies and challenges for every project in drug development. However, these studies should be mapped out being mindful of these major considerations, which tie nicely together to achieve “QBD” – Quality by Design:

  • Identify the key experiments that will need to be conducted, their purpose, and what beneficial information their execution could reveal.
  • Set your objective to test as many variables as possible – a correctly designed set of experiments can confront as many as 3-5 variables concurrently.
  • Know the equipment at hand, and what materials need to be used.
  • Ensure that you have a clear-cut means of recording and documenting every observation at every stage of the process being challenged.
  • Be attentive: review and dissect your observations to see if they reveal new issues in the process that may not have been otherwise considered.
  • Be flexible in your experiment design: assess your visual and written observations; discuss what worked, didn’t work, and what changes to the experiments you can make for the next round. Be open minded in even challenging new grades or vendors of raw materials, orders of addition, etc.
  • Analytical methods need to be onboard, fully developed, and stability indicating. Given proper expertise and a clear definition of the properties and characteristics of the end product, it should be possible to identify formulation and process within 10 to 15 sets of experiments.

Consider Manufacturing a Small Scale Batch To Test Your Product and Process Prototype

Once a possible prototype is in hand, it’s very beneficial to make a small-scale batch. Small scale feasibility studies can provide helpful feedback in optimizing key process parameters, such as:

  • Mixing speeds and times
  • Drying times
  • Tablet compression
  • Weight
  • Thickness
  • Coating

Feasibility studies confirm that the parameters are cut right, and consistently deliver quality when manufacturing a product.

Another great idea is to put a feasibility lot on stability under accelerated conditions for three to six months. We know, we know – waiting six months can test your patience, but in reality, that six months will reveal whether or not you’ve got a product, and it’s worth the wait. Assuming that all is well after the waiting period, scaling up your manufacturing process can be explored.

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