Of Course I Understand Compliance – I’m a Dad

I’d like to welcome back an integral part of the McCormick LifeScience Team, Mark Goodsell, a Quality professional with over 20 years GXP experience.

Your turn Mark!

Bringing up three boys in a busy household was always filled with challenges. Nothing brought about more tension at home than when my wife would tell the kids to “clean” and rarely was the end result close to Mom’s expectations. I told her that just saying “clean” was not enough, and that the boys needed her instructions to be interpreted based upon what needed to be cleaned. Setting out to reestablish peace and quiet, I broke each cleaning chore down to individual steps. Instructions to clean the kitchen became a detailed list, i.e., empty the dishwasher, reload the dirty dishes, put the silverware away, empty the recycling, sweep the floor . . . I even included some extra motivation in the form of money or treats hidden somewhere along their cleaning path to make it more fun. Eventually, tranquility was restored.

OK, it might be a stretch, but in a similar manner, the current Good Manufacturing Practices (cGMPs), specified in the Code of Federal Regulations, are full of requirements, but painfully short on details. The regulations are intentionally vague so that each company can interpret the requirements in a manner that is consistent with their individual business model and not have to comply with one size fits all cookie-cutter regulations. Unfortunately, people often don’t understand this concept of the GMPs and instead think they are a rigid set of rules.

As a Quality professional, it is my job to provide the details by formulating a strategy that allows a company to comply with the regulations based upon their individual situation. Although the regulations are the same, the quality systems for a company with a commercial product will be very different than what is needed to support early phase clinical studies. In addition, with all the different products and processes, as well as the many paths taken in the development phase, each company faces different challenges requiring different approaches to regulatory compliance.

I carry a small regulations book that is about 6″ x 4,” the cGMP regulations defined in 21CFR Parts 210 & 211 take up 48 pages of that little book. By my estimation, that’s only about eight square feet of actual cGMP regulations. Yet there are literally hundreds of pages to help interpret the cGMPs in the form of guidance documents, FDA enforcement reports, compendia such as the USP, as well as industry-related magazines and books. This doesn’t include the multitude of training opportunities available through classes, conferences, and web-based training. I may not know everything, but with all of the available resources, I can always find pertinent references to help provide background and guidance in finding effective quality solutions.

Despite all of the printed resources, the best tool may be that of experience. Chances are there are many individuals who have had to navigate the same dangerous waters that you may be trying to cross. Whether it is a consultant, a previous colleague, or a vendor representative, industry professionals may be the single best resource for cutting through the bumpy seas towards GMP compliance. When you put together the regulations, the available written references and individuals who have the experience, you can build a direct path towards effective cGMP compliance for your company. Even consultants seek out the advice of current and previous colleagues.

As always, a little motivation always helps. While I don’t recommend leaving money around in different locations in your office, management needs to understand how a particular strategy can help the company in the long run.

• Determine what requirements or regulations are applicable given the scope of the company.
• Locate guidance documents, compendia, and reference information that can apply to the work.
• Don’t reinvent the wheel, most likely some other company or companies are already working on a similar product and references exist. Find people that have lived through the same issues that you face.