As consumer goods companies are dealing with increasing regulatory requirements, market fragmentation, risk, and demand for late-stage product customization, they are extending their reliance on external suppliers to help bring products to market. With short lead times and high SKU proliferation, the production environment is already complex for these external packagers and manufacturers, but within the heavily regulated pharmaceutical and healthcare market, the burden of proof is even higher.
Those who are able to demonstrate proper product handling within regulated industries stand to profit from double-digit industry growth. Growth in contract packaging is largely being driven by the pharmaceutical and healthcare market. The sector is expanding at around 15% per year, a trend which is expected to continue at least through 2021.
“We are seeing business growth with our Rx pharmaceutical customers, so staying compliant with pharma regulations, particularly Part 11 regulations, is a huge mandate for us,” says Jennifer Squillante, Quality Manager at Unette, a contract manufacturing company.
Anyone hoping to profit from that growth has their work cut out. The packaging of pharmaceutical and healthcare products involves more responsibility than ever. A plethora of regulations, compliance protocols, warning labels, protection standards, and security requirements places a tremendous burden on contract packagers.
A survey by the Contract Packaging Association revealed that 70% of contract packaging and contract manufacturing companies are concerned that the regulatory environment could negatively impact business in the coming years.
Those looking to stay ahead of the evolving regulations must stay diligent. “We are regulated by the FDA and the DEA, and as such, we are always reviewing new white papers and guidelines to continuously improve our processes,” comments Sarah Faison, Director of Sales & Marketing at Praxis, contract packager to pharmaceuticals and health and beauty brands.
On top of heightened regulatory control, brand customers are demanding a more agile supply chain to drive out costs in response to tighter margins. They expect suppliers to harness sophisticated quality control and compliance systems. There is no longer any room for manual processes, delays in information relay, or general supply chain inefficiency.
How are successful contract packers and manufacturers rising to the challenge? Here are some of the ways they are coping with burgeoning requirements and gaining ground in these fields:
“To stay on top of the evolving compliance and quality requirements, I regularly visit the ORA FOIA Electronic Reading Room to avoid pitfalls of other companies have fallen victim to,” remarks Squillante. “I also subscribe to FDA electronic notifications — MedWatch, Cosmetic and Dietary Supplement news and such — so that when there are changes or issues we need to be aware of in the industry, I can immediately take action.”
“We have been operating our legacy system for many years, and migrating towards Nulogy’s electronic signatures, and mobile devices, has been a paradigm shift as our team was used to pen and paper recording,” says Squillante. “There is a challenge in helping our employees embrace the change of an electronic system rather than a paper-based system. There is also a challenge in purchasing a service from a third party to control our electronic records, in that the burden of proof is on our company, as the end user, to ensure that the product was designed and developed in compliance with 21 CFR part 11.”
Jason is a co-founder, CEO and brand ambassador for Nulogy. He is focused on corporate development, executive leadership, and understanding the evolving landscape of Nulogy’s clients. He is also on Nulogy’s board and speaks throughout the industry on the agile supply chain.