Thinking Outside the GMP Box

The mission of GMP guidelines and directives to guide the pharmaceutical and biotechnology industries can often be disrupted due to a lack of understanding of their contents.  

Companies feel the pressure of:

  • Delivering products to the market on time
  • Ruthless competition
  • Patient expectations

Often, they do not understand the GMP guidelines and directives, even if they read them word for word. Moreover one of the inspections carried out by two health authorities’ inspectors may have different findings and results from the other.

There's no point in making already complex guidelines even more complicated. 

However, when we try to look at GMP from a different perspective, it is possible to understand that it is not that complicated. For example, when dealing with deviations, the person or personnel researching the deviation ask wrong and off-target questions, making it difficult to get to the root cause of the deviation, and even the root cause cannot be determined in most cases. 

It is a fact that the effectiveness of personnel training, which is a GMP obligation and one of the main issues that the health authority questions during every inspection, is controversial.

You cannot get rid of responsibility by just planning training; you can understand from the findings you receive during the audits that there is no benefit in keeping all the staff captive almost full-time in a stuffy environment with very boring and outdated presentations.

Another important example of not considering GMP from a different perspective is not feeling the need to research what is happening in other industries and not adapting the best practices in other industries to their processes. When this approach is examined in detail, the added value it will bring to the company will be quite high.

An operator who detects a problem occurring in the production environment is responsible for immediately reporting the problem to his manager.

However, managers in pharmaceutical companies that strive to be GMP compliant, often try to find a solution to the problem only through documents, without leaving their offices, that is, without conducting a crime scene investigation. Whereas on-site observation, ‘Gemba Walks’ will approach the problem more realistically by examining it and asking appropriate and intelligent questions of the operators and other personnel who witnessed the incident.

Published on Jun 25, 2024 by Mustafa Edik