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b a c k p a g e The five stages of GMP grief In 1969, Swiss psychiatrist Elis- abeth Kübler-Ross revolutionized the way terminally ill patients were treated with the publication of her worldwide best seller, On Death and Dying. Kübler-Ross divided the grieving process into five phases: denial, anger, bargaining, depres- sion, and acceptance. Organizations subject to current Good Manufac- turing Practice (GMP) compliance can go through these stages as well, especially when GMP compliance is a new requirement. While GMPs have always been required in theory for active phar- maceutical ingredients (APIs), the FDA often found itself at odds with the industry when trying to make the case for GMP controls. With the publication of ICH Q7 Good Manufac- turing Practice Guidance for Active Phar- maceutical Ingredients in 1996, the true alignment began. Even over the last ten years, increased FDA scrutiny has led to a growing emphasis on GMPs in compounding pharmacies. In such cases, GMPs can seem new. (Even the "current" aspect of a GMP prin- ciple can seem like the introduction of a totally new requirement to an organization as it struggles to regain its knowledge and comfort base.) As organizations evolve over time, changes to the quality system or the addition of new businesses driv- ers emphasize areas of GMPs that weren't needed before. As a result, an organization can go through the stages of "GMP grief" multiple times. In the denial phase, an orga- nization learns about the initial GMP requirements and tries to think of ways to avoid compliance. For example, a contract laboratory might decide to refuse pharmaceu- tical samples, or a synthetic chemis- try business may limit its production to substances before the API start- ing material. But this attitude in a business that must follow GMPs is guaranteed to lead to sanctions. Denial on the part of management is surely subconscious, as no organiza- tion will ignore a statutory require- ment. However, the subconscious belief that GMPs are not real will cause an organization to make GMP compliance a lower priority and starve it of resources while tackling "real problems." Organizations that survive the denial phase may enter the anger phase, in which they decide to fight certain aspects of GMP compli- ance. Maybe they define "critical" instrumentation so tightly that they conclude that nothing needs to be qualified or calibrated. Maybe they decide to fight an FDA 483 finding instead of asking about the origin of the problem. A GMP organization in this phase can make a small com- pliance problem into a big problem worthy of a Warning Letter. An organization in the bargaining phase is beginning to take compliance seriously but only in pieces. Major systems will be brought into compli- ance only to "satisfy the agency." For example, the chromatography system in a laboratory may be validated and have a unique login for each analyst, while the standalone infrared spectro- photometer, with its integrated library of compounds, continues to have one lab-wide login and no validation cali- bration since the lab "compares these to the standard by hand anyway." In the depression phase, GMP compliance is enforced organization wide, but the rest of the organization sees the quality unit as a police force constantly looking for ways to slow down production and erode profits. The "cost of quality" is highest in this phase, because quality systems are at their most bureaucratic—they must be imposed in detail or they will not be followed. The organi- zation now catches GMP problems that it missed in earlier phases but cannot realize the cost savings of a successful quality system. Lessons learned from failures are not imple- mented, because "quality is the job of the quality unit." Many organiza- tions get stuck in this phase. In the final phase, acceptance, the "cost of quality" becomes less of a negative and is often seen as a motivational force for improvement. GMP compliance and quality are everyone's responsibility, so quality is integrated into processes during their design. The quality unit is part of the organization's growth strate- gies from the beginning rather than the bearer of bad news when asked to review a "finished system." Quality problems are resolved collaboratively with input from all stakeholders, and management no longer views quality as overhead but rather as part of the product itself. By working through the stages of GMP grief, organizations can make quality second nature and benefit from a system that runs smoothly and adds to long-term profitability. T&C Joe McGuinness is an independent con- sultant with EA S Consulting Group (571 4 47 55 0 0 , www.easconsulting

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