When it comes to understanding what sort mindset is required in order to help implement and adhere to cGMP standards, here are a few things to consider:

• it is the baseline of all biomanufacturing workflows. Point blank. It’s the basics, it’s the “way of life” in a biomanufacturing facility, and it is (gratefully) not an exception.
• is your approach, doing it correctly upfront/the first time? If not, why not? The end product is often injected in an individual and there are no second chances after doing so. Without cGMP, you cannot ensure the safety of the product that will help increase the safety of the patient.
• are you detail oriented or able to adhere to set SOPs? The pharmaceutical industry is laden with regulations and for good reason. As mentioned above, can you help ensure the safety and quality of the process, product, and ultimately the intended patient?
• intent-to-action. In short, if you stated a task was done, was it in fact completed?
• with that being said, document, document, document (to infinity). In this space, if it’s not documented, it didn’t occur. Good documentation helps confirm the process used to produce and manufacture the product. It can also help ensure the validity of the product’s safety.
• proactively look for ways to identify and then mitigate risks. This is all about patient safety. You, a friend, or family member may also end up with the drug product you are helping manufacture.
• if you’re not sure, don’t be afraid to ask questions.

Overall, keep in mind that pharmaceutical quality affects every individual. For that reason, the Food and Drug Administration (FDA) regulates the quality of every manufactured pharmaceutical product in the United States very carefully. If you operate in the pharmaceutical industry in any way and especially on the front lines producing and manufacturing these potential life-altering and life-saving products, having a cGMP mindset helps ease the massive burden of ensuring each of us (as patients) are safe.

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Image source: https://www.europeanpharmaceuticalreview.com/article/164036/continuous-biomanufacturing-where-are-we-now/