Someone once said (sorry, I could not find who said this), “Baseball is just running and hitting and throwing. What is so hard about that?” When broken down into its basic pieces, that is really all that baseball is… physically! There is much, much more than that, however, for those that play the game well. Baseball is known as a game of intricacies. Some call it a game of thinking. Others have said that you can see a game every day for 50 years and still see something new and learn something every day.
The business world, especially in a pharmaceutical company, is similar in a lot of ways. What are our basics? I can name a few:
- Documentation – meticulously creating, retaining, reviewing, and approving the recorded proof that we follow cGMP requirements – examples include: batch records, analytical data, log books
- Following procedures – adhering to the procedures or methods or instructions provided – examples include: following SOPs/batch records/work instructions/methods, training,
- Product protection – ensuring that nothing unwanted can enter or contaminate our products – examples include: closed systems, cleaning systems/procedures/validation, gowning
- Developing robust products and processes – ensuring that the products, processes, and equipment we use will operate accurately, repeatably, and as designed – examples include: process design/batch records, product design space, process capability, maintenance, reliability, automation/fool-proofing
- Identifying and mitigating risks – determining what can go wrong and implementing steps to prevent it – examples include: redundant systems, inspection systems, validation, verification, qualification
- Finding, identifying, eliminating, and preventing problems – monitoring processes in ways that allow us to observe or predict when things could go wrong, then preventing their recurrence – examples include: trend analysis, metrics, investigations, CAPA
Certainly, these are just a few of the key basics that apply to our business, but these likely apply most to the regulated industry audience. So, all we have to do is these 6 things to perform well. Sounds simple. However, we all know that each item above requires extensive knowledge, ongoing oversight, diligence, attention to detail, and commitment. To do all this well day-to-day is a remarkable task. But, when you consider the life-saving and life-changing products we provide, it is worth it.
Thank you for doing the “basics” of our business so well! Have a great day!
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