Good manufacturing practices (GMPs) are manufacturing guidelines for ensuring the safety and efficacy of drug products and medical devices. The GMPs are legal regulations, based on the United States Food, Drug and Cosmetic Act. But, why do we need the GMPs? Shouldn't we, as knowledgeable individuals, groups, and companies, be able to figure out how to produce drugs and devices that are safe and effective?
The answer is "yes and no." We are knowledgeable, but we do need our work to be guided by stated expectations. All aspects of a complex society require rules. Why should our industry be any different? After all, these products can be life-saving or, if impure, a serious health threat. Even lawnmower manufacturers and bridge builders are adopting standardized manufacturing rules.
The GMPs are promulgated by FDA. However, FDA is part of the U.S. Public Health Service (USPHS). Ensuring the safety of drinking water is a good example of USPHS's role. Water can be an efficient means of transmitting diseases, such as cholera, cryptosporidium, and enteroviruses. USPHS's approach prevents illness by protecting water sources and minimizing the risk of disease through filtration and disinfection. Likewise, FDA is entrusted with ensuring public health — preventing harm to the public from drugs and medical devices. The agency also is charged with ensuring products are efficacious. These are consequences of a public health approach: FDA oversees proactive measures to ensure these objectives are routinely met, which is where GMPs fit in.
Requirements vs. Outcomes
If you look at the manufacturing systems of three different pharmaceutical companies, you will likely find three different sets of terminology, procedures, and activities designed to ensure compliance with GMPs. How can this be, if all three are following the GMPs?
The answer is easy: the GMPs are not checklists. They do not describe how work is to be performed; they define the required outcome of the work performed. How an organization chooses to achieve these outcomes is determined by that organization.
For example, the GMPs do not state that a documentation system is required; however, the phrase "written procedures shall be established and followed for..." is used throughout the GMP regulations. If a documentation system is not in place, how else can the required outcome, specifically that written procedures be established and followed, be achieved?
Despite what some critics of the GMPs have stated, they are flexible. They require manufacturers to evaluate the outcome articulated in the regulation, assess how that outcome can best be achieved, and then implement it. Finally, they must ensure that compliance with GMPs can be demonstrated — for example, to FDA inspectors and collaborators.