While we won’t make the direct connection that the most successful pharmaceutical companies can attribute their success directly from strictly adhering to regulations, in our experience, the big guns in the industry know auditors, regulations, and compliance like the back of their hand. But what do they know about their facilities as those facilities relate to regulatory organizations? Nothing that you don’t. There aren’t any secret passwords or hidden lists on pharmaceutical safety. Instead, the big guns do the important things really, really well. Here are those important things they know so much about:
They adhere to stricter storage requirements.
A weird one to start off with, sure. However, it’s a minor change that can have such a great impact, we’d be disappointed if you weren't running to change your storage requirement documentation right now. Adhering to “tighter-than-what-the-auditor-says” storage conditions will only benefit you. Alarms will go off sooner, helping you save money on lost product. Also, it looks really good in the auditor’s eyes if you go the extra mile.
They are in constant contact with their auditors.
And we mean CONSTANT. We’d be surprised if each of largest 10 pharma companies didn't have a robust internal auditing team and multiple FDA contacts who were showing up at their door to check over things on an incredibly frequent basis. For example, when testing or manufacturing a new product, pharma companies have to go through months and many times years of audits, third party and FDA testing, marketing guidelines, and distribution practices validation. No matter which stage of the process you are in, you get visited by regulatory agencies. So, establish open communication with both your internal auditing team and your external auditor. You need to stay informed to ensure your products are safe and your business is successful.
Every part of their testing, manufacturing, storage, and distribution process is validated and documented.
That’s right, every part. If you can prove why you do something, how you do it, and what the effects of doing it are, you are golden in the pharmaceutical world. The top dogs in the pharma industry don’t institute a new practice or product without qualifying it, verifying it, and validating it. Also, they understand how one change in manufacturing could have a ripple effect on some standard in storage.
They adapt to regulation changes quickly and completely.
Just because regulations seem to take forever to change, doesn't mean your company has to take forever to change with them. The disadvantages that come with waiting until the last day to update your processes to comply with recently changed regulations significantly outweigh the advantages (we couldn't even think of any). The largest pharma companies institute changes, at the latest, immediately after regulations are changed. They have a leg up on the competition by keeping up-to-date on the possible regulation shifts that will affect their facilities and impact their business processes.
