Dec 19, 2013 | Free Downloads | |Share This Article
In August, I traveled to Phoenix to videotape a presentation for Natural Products INSIDER’s Digital Summit. The presentation, entitled “A Guide to SOPs and Compliance for Dietary Supplement Distributors,” goes into much more detail than our February blog post on the same subject (which you can read here: http://bit.ly/YGTQWd).
Rosanne Sylvia-Heeter, Director of cGMP Compliance at Polaris, is always chanting the FDA compliance mantra, “If it’s not documented, it didn’t happen.” As I worked on the blog post with her last winter, I was struck by the amount of documentation actually needed to comply with 21 CFR Part 111 distribution regulations. As we worked on the Digital Summit presentation this summer, I was struck by something else. In the course of simply maintaining a residence, members of my household actually perform a lot those Part 111 activities. And so do yours.
The big difference is that we don’t have to write it all down.
For example, distributors have to maintain their grounds, their facilities, and all the equipment inside. So do we. I clean my “facilities” on a set schedule, selecting cleaning agents that are appropriate to the task, and safe for our pets, the planet, and the finished surfaces to which I apply them. Most maintenance activities at our facility are performed by my “business” partner of 25 years. His responsibilities include waste management, pest control, and any activity that requires duct tape, a plunger, power tools, or an arm span over 61 inches. We don’t personally maintain the outside of our property, nor do we directly engage outside service providers. Because we live in a townhome, all vendor selection and management procedures have been effectively outsourced to our home owners’ association. If we wanted more say in that process, we could join a committee, but we don’t, so we won’t.
Distributors are responsible for verifying the quality of the shipments they receive from their contract manufacturers. Whenever UPS drops a package at our front door, the first thing I do is inspect its contents. Is it what I ordered? Has it survived the trip undamaged? How does it compare to product specifications on the manufacturer’s website? If it passes initial inspection, distributors must store the product in suitable environmental conditions. Anyone who’s inadvertently left ice cream to melt in the trunk in summer or caulk to freeze in the trunk in winter can appreciate that requirement. A distributor requires an inventory management system to keep track of product in its warehouse. In our facility, we, too, manage inventory. We use a low-tech memory-based system – my memory, to be precise. It’s a satisfyingly simple solution, but, admittedly, not uniformly effective. While the scheme enjoys moderate success in some parts of the house, the garage has Warning Letter written all over it.
Distributors are required to hire qualified personnel. I’m not sure there’s a parallel for “hiring qualified personnel” in my extended household analogy, but the bank did qualify us to be homeowners. That must count for something. Distributors are also required to keep their staff well-trained. On an as-needed basis, my business partner and I have sought out training classes to keep current with important trends and regulations. Recently, we attended an investment strategies seminar, which included the requisite rubber chicken dinner bribe, and a lead paint remediation course, for which we earned certificates of completion. (I should file those certificates in our “Training Records,” except I don’t know where they got to – they’re probably in the garage.)
We have a CAPA program. It kicks into full swing whenever we see a water stain on the ceiling below a second-floor bathroom, or a grease stain on the driveway below a second-rate minivan. We have an unbiased Quality Assurance program; I inspect the result of household projects in which I had no hand (“Needs more spackle.”) and my business partner does the same (“Needs more curry.”) Excelling in this particular QA activity, my business partner also does most of the batch sampling in our facility, particularly when the first batch of cookies comes out of the oven. (That’s a joke. I don’t bake.)
Unlike our regulated counterparts, however, none of us homeowners have to document these activities in a set of Standard Operating Procedures. Occasionally, we may need to leave the babysitter a note, or dash off a set of instructions for a temporary delegate, but by and large, we all get to operate without any formally documented plan. We also get to operate without having to prove that we did, indeed, execute the plan. Few of us would dream of committing pen to paper each time we emptied a lint trap, wiped down a counter, or adjusted the temperature on the hot water heater. The extra work load would be staggering.
Yet that’s just what regulated companies face.
Dietary supplement distributors may be interested in viewing INSIDER’s Digital Summit to learn more about (1) how to comply with supplement distribution regulations, (2) what SOPs are required to comply, and (3) what activities and documentation are most critical, so you can allocate resources to best effect.
Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.
Laurie Meehan has been with Polaris Compliance Consultants, Inc. since 2008, writing SOPs and managing a variety of internal and external projects related to training, technology, social media, and documentation. Prior to joining Polaris, she worked at a major telecommunication research and development company where she wrote requirements for telecom services and products, and spoke at numerous industry forums. Ms. Meehan also teaches math at a local university and tutors high school students in math and SAT prep. Ms. Meehan holds a Bachelor of Arts degree in computer science from La Salle University and a Master's degree in computer science from Drexel University. She can be reached at email@example.com
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