Throughout this blog series, I have asked a number of Clarkston experts to discuss several different topics with respect to Quality Systems Validation. They have discussed FDA’s changing perspective on the consumer products (CP) industry and addressed whether quality systems validation applies to the consumer products industry. While it’s a relatively infrequent occurrence, I have seen an uptick in the severity of FDA inspection outcomes with a growing percentage of FDA inspections culminating in Official or Voluntary Actions Indicated (FDA’s way of noting noncompliance). FDA’s heightened sense of scrutiny is not without reason, as consumer products companies from cosmetics to tobacco are expanding product lines to sustain growth. As this trend continues, CP companies should be asking themselves the questions that have been shared in previous blog posts, making sure their organizations comply with FDA regulations.

While quality systems validation may seem like a daunting task, I have seen this trend before within the medical device industry. Similarly, medical device manufacturers struggled to adopt pharmaceutical validation practices and meet stricter FDA guidelines. Now that this trend is occurring in the consumer products sector, I am proud to say that many of our clients are approaching Clarkston for quality systems validation support. I know that validation may not be CP companies’ highest priority initiatives and understand the operational strain validation can have on an organization. This is why I encourage our teams to build sufficient, yet scalable validation solutions that empower organizations, not slow them down.

As the leader of Clarkston’s Consumer Products Practice, I have partnered with our Life Sciences Practice to leverage their many years of validation experience. This has allowed my team to provide consumer products clients validation expertise in an industry-relevant context. If your CP company is manufacturing and marketing products that are moving from traditional consumer products into the pharmaceutical drug arena, I would be thrilled to share some more detailed and practical advice to help you navigate this new territory.