Reading PharmTech’s October article on Critical Challenges to Implementing QbD gave me the impression that we might have the road map to Moksha or Nirvana. Unfortunately that was not meant to be. Somehow there is a belief that PAT in pharmaceutical industry is the roadmap to QBD, pharmaceutical industry salvation. In this article, blame of not achieving “pharmaceutical industry salvation” has been attributed to unfamiliarity with the used equipment and corporate culture. I do not believe either of these is completely true.
If a company is authorizing installation of equipment that is not understood by the operating personnel then we have a two-fold problem. 1) Personnel do not understand the basics of the process needs and have installed a wrong equipment, and 2) Authorizing managers have not asked right questions to challenge the expenditure. This is a clear case of “lack of understanding of the fundamentals.” It is a case of trying to climb Mount Everest without understanding the challenge and proper gear.
Corporate culture has nothing to do with QBD or PAT. Companies have a basic goal (i.e., deliver the expected profit to their stakeholders). They have been able to deliver the profits using inefficient processes. They do not see any need to change. Consumers have paid for these inefficiencies, as they want to extend their life.
Unless we totally understand the fundamentals of active pharmaceutical ingredient (API) manufacturing and API-excipient blending process (i.e., chemical interaction and operating parameters), we will not have command of the process (i.e., first time quality will be elusive). Complete understanding of the interaction and the right instruments will tell us where we have gone “off-course” and how to command the process. Until we have the understanding of fundamentals and use them properly, we will not have a perfect process or close to it that will deliver quality. Innovation will automatically come, as it is a human trait.
Innovation has to evolve at the profit making company rather than at an external agency, an expenditure body. Regulatory bodies can demand quality and the operating companies have to deliver quality. However, any expenditure that will reduce their profit margins like now, will meet resistance.
I have to ask a question: “Does anyone really understand QBD and PAT” and if so, can the answer be written in one sentence not exceeding 25 words? If we can, we have simplified the definition of pharmaceutical innovation and we will meet the quality objectives.