Tuesday, March 16, 2010

Alternate Interpretation of Pharmaceutical TLAs; Three-letter Acronyms

Around 2001 Dr. Ajaz Hussain and his colleagues at USFDA-based on their experiences-suggested and encouraged the global pharmaceutical industry to improve their process technologies so that the manufacturing practices could be simplified and quality products produced with minimum interference. It has been a noble effort and led to the coining of two acronyms QBA and QBD. Based on the amount of printed material, I have seen considerable analysis and discussion on how to move from “A” to “D”. I would like to restate these acronyms differently in a lighter perspective with the hope that we will improve our manufacturing technologies.

In the current state of manufacture of active pharmaceutical ingredients (APIs) and formulated products, we repeatedly check intermediates and the final product for quality. This practice has been appropriately called “Quality by Analysis” (QBA). It not only prolongs the manufacturing cycles and processes but also impacts the whole business process through increased inventories of raw materials, in-process materials and finished goods. The whole business process becomes complex and lowers profitability.

I would like to rename the acronym QBA and call it “Quality by Aggravation”. Why aggravation? Meticulous sampling and analysis is necessary to ensure we follow protocol at each step. This prolongs and extends the batch cycle times. Everyone gets aggravated if anything is not done as per procedures. Intermediate product not meeting specifications either is reworked or disposed of. All this costs money. In addition, it increases work in process inventories that affects the cash flow. Additional investment could be needed to quarantine intermediates and all this lower profits. In doing all these we aggravate our life and it has been our way of life.

Aggravation (mental and financial) in pharmaceutical manufacturing processes can be alleviated if we have complete command of the process chemistry and its unit operations so that we can produce quality product with minimum or no intermediate samplings. Since we will produce products based on “quality by design” QBD, I would also like to rename this acronym to “Quality by Desire”. We will have quality production. This will simplify manufacturing process and life. Our desire to have an excellent process could significantly reduce our aggravation. It even could be eliminated.

Pharmaceutical products have to meet the strictest of the quality standards no matter how the products are produced. The question that needs to be put on the table is what should be our method of choosing to produce a quality product. “Quality by Aggravation” or “Quality by Desire” are the two choices and we have to pick one.

Most of us know the correct answer. All of us have a choice and can do what we desire. Since maximizing profitability is the ultimate goal, I am not sure why we have avoided the right path for so long. Is the industry waiting for disruptive innovation?

QBA and QBD methods are applicable to everything we do in life. When we desire anything, we make sure that our methods to achieve the goals are swift and simple. We always pick QBD. Our choice in the manufacture of pharmaceuticals and their components is “Quality by Aggravation” or “Quality by Desire”. You pick.

Girish Malhotra, PE
EPCOT International

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