What is Change Control in Pharma?
Pharma change control is an interesting challenge because it is so heavily regulated by various governmental organizations. When there are changes that need to be made to a drug, these agencies develop directives and checkpoints that must be met by pharmaceutical companies along the way. Processes that can move with these changes quickly in order to avoid penalties as well as harm to patients is essential in this field and thus makes pharma change control of the upmost importance. There is the combination of the medical directive but also studies and documentation of those studies that are required of any product that has been manufactured in the pharmaceutical world.
The documentation in pharmaceutical change control is crucial because it is what informs all of your teams that the change is being done the right way. All regulations must be carefully considered when updating and pharmaceutical products. Any material change or methodology change in how drugs are manufactured must be in compliance with whatever the governmental agencies and the science determines are safe for public consumption. Any failure in that part of the process can result in major damage to human life and thus resulting in major problems for the business, so skipping steps will not work here.
Change control in pharma also requires a deep understanding of both the scientific and fiduciary responsibilities of any pharmaceutical company, so selecting the right project manager can be more challenging than in most other industries. The medical engineering that goes behind a product is not always created with regulations in mind, but rather with scientific innovation being the main driver. Finding someone who can appreciate and understand the importance of innovation while still understanding the need for process and order when implementing any change in the medical world is the only way to execute change control effectively in this field.
Since the field is so complex, having a regulatory group like a change control committee or board would be a great way to analyze and test any change request that came around. This way you can get input from a wider range of team members who can see the same problem for various angles and sections of the industry. It is still important to select a smaller number of people from within that group to take the lead in regards to project management, but having a change control board can allow for more free collaboration and open discussion about the best path forward. Pharma change control has an impact that can reverberate throughout a community in drastic ways, so creating a process and a regulatory body to carry out that process can make an enormous difference.
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