Continuous Processing in Pharmaceutical Manufacturing

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Matthew J. Mollan Jr., Ph.D. and Mayur Lodaya, Ph.D., Pfizer Inc.

Regulatory Aspects

The FDA regulatory definition of batch is:

A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture [5].

It appears, therefore, that regulatory definitions are already in place to support the concept of a period of time, being a “batch” for the sake of tracking and quality assurance. This interpretation, if accepted, would assist in moving to continuous processing which is by definition a single cycle of manufacture.

The overall issue of new technology introduction into the pharmaceutical manufacturing area has been very restrained, however this is changing quite rapidly from the regulatory perspective. The FDA has recently issued a draft guidance [2] to the pharmaceutical industry in its; Guidance for Industry “PAT ­ A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance.” The goal of this guidance is to describe a regulatory framework on which industry and government can together increase the level of innovative pharmaceutical manufacturing technologies by the removal of actual and perceived barriers. The draft guidance document [2] states, “Process Analytical Technology, or PAT, should help manufacturers develop and implement new efficient tools for use during pharmaceutical development, manufacturing, and quality assurance while maintaining or improving the current level of product quality assurance.” The background of this guidance is centered around the concept that while conventional pharmaceutical manufacturing is accomplished using batch mode, new opportunities exist to improve the efficiency and quality of the pharmaceutical manufacturing process. This is an attempt to introduce 21st century technology into the pharmaceutical industry to better respond to the rapidly changing marketplace for ethical pharmaceutical products. The utilizing of new approaches to pharmaceutical manufacturing, while maintaining the concept that quality cannot be tested into a product, but must be built in by design, leads to the concept of continuous processing. In specific, the draft guidance document [2] states, “Facilitating continuous processing to improve efficiency and manage variability.” These regulatory statements should further encourage pharmaceutical manufacturers to begin to exploit the benefits of continuous processing.

 

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