Documentation… the Basis of our “Packaging?!”

Once again I welcome back one of my favorite members of the McCormick LifeScience Consultants, LLC team, Jacob Cooper, Quality Systems and Regulatory Operations Consultant. He loved writing last month’s issue so much that he came back begging to do it again! (right Jake?!?!?!)

Take it away!

Have you ever noticed how, generally speaking, Japanese products (particularly those for the Japanese market) are packaged really well? You can find Pinterests and YouTubes and design blogs all dedicated to the subject. The care and effort dedicated to making a satisfying package is a way of telling the end user what the package contains is of equally high quality.

A story goes that a certain firm, in evaluating vendors for a new widget, refused at the dock the sample shipment from another company with just a glance at how it was wrapped for shipment.

(Before I go on, let’s just quickly translate this to our business. If our product is a pharmaceutical, then in a very real way, the packaging is our documentation. After all, from a submission standpoint, the package insert is at the very top of the pyramid, and all the company’s documentation serves to support and defend that. Okay, back to the story.)

Apparently, the hopeful vendor was shocked when their sample shipment was returned unopened. The conversation went something like this . . .

Vendor: “How can you refuse our business when you don’t even know how good our product is?”

Purchaser: “If your product is anything like the shoddy packaging you sent it in, then we know it’s not good enough.”

The documents that we generate are fundamentally about creating trust.

jan2014After all, for pre-commercial companies, with the exception of the clinical trial sites, documents are the beginning and end of what the rest of the world knows we’ve been doing. So it stands to reason that, regulatory requirements notwithstanding, a company would want its documents to be of the highest quality, be identifiable, have the correct strength (be accurate and meaningful for its life), and be pure (contain only what it needs to contain).

See what I did there?

Documents are the proxy for our product, and they are the packaging by which everyone knows our product is as good as we claim. So it stands to reason that the same standards we apply to our product we should apply to our documentation.

Document control is our tool-set to ensure the trustworthiness of our documents. At its most basic, it’s the GMPs applied to words.

The requirements are pretty basic:

  • Authorship and approval. Did the individual most qualified write this? Was it reviewed and approved by the proper other individuals?
  • Distribution. Are documents available for use to those who need them and not to those who don’t? Are they distributed in a timely manner?
  • Version control. Are changes also written, reviewed and approved by the right individuals? Once a document has changed, is the previous version no longer available to prevent confusion?

In short, can we trust that these are the best documents possible?

The controls that we put in place to manage documentation help create that trust. We don’t need a fancy EDMS (just try finding an article about document control that’s not shilling for one system or another), but we do need to understand what the foundations are made of.

In a very real way, if the documentation reviewed in an inspection or a submission is shoddy, the recipient has every reason to turn it away at the dock.

The great thing about having high quality, trustworthy documents is that, for us, they’re not just an elegant and well-made package. They actually make the product itself better. Since every single aspect of pharmaceutical development and testing is described and controlled by documents, the quality of those documents has a direct impact on the quality of what is being developed and tested.

Toto's Tips

  • Documentation is the foundation of trust, both for what we do, and how we tell the world about it.
  • Keep the basics in mind at all times, and evaluate your system against them from time to time. Consider that documents can also be “manufactured” under GMPs.