JASON THAM, CEO at Nulogy, looks at how managing complexity within pharmaceutical and healthcare packaging can create growth…
Increasing regulatory requirements, market fragmentation, risk, and demand for late-stage product customisation are driving CPG demand for 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 digitise their supply chain to demonstrate proper product handling within regulated industries stand to profit from double-digit industry growth. Growth in contract packing 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 pharmaceutical customers, so staying compliant with regulations, particularly part 11 regulations, is of high importance to us,” says Jennifer Squillante, Compliance Officer at Unette, a contract manufacturing company that services customers in regulated industries.
AHEAD OF THE REGS
But 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 packers.
A survey by the Contract Packaging Association revealed that 70% of contract packing 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 packer 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:
Current Good Manufacturing Practice (cGMP) guidelines from the U.S. FDA encompass the manufacture, processing, and packaging, as well as any other activity that could impact product quality or safety. Those following these practices minimise production risks that can’t be eliminated through testing of the final product. Contract packers are advised to adopt software with workflows that adhere to GMP and other industry standards.
“To stay on top of the evolving compliance and quality requirements, I regularly visit the FDA’s ORA FOIA Electronic Reading Room to avoid pitfalls of other companies have fallen victim to,” remarks Squillante. “I also subscribe to FDA electronic notifications including MedWatch, Cosmetic and Dietary Supplement news.”
Rules are being strictly enforced in the U.S., Europe, and around the globe concerning Electronic Record and Signatures (ERES). Electronic records must demonstrate that manufactured product data is electronically captured, manipulated, extracted, and coded precisely. A complete audit trail must exist. Electronic signatures must be carefully managed. Business applications used by contract packagers should seamlessly address EREC requirements.
“We have been operating our legacy system for many years and migrating towards Nulogy’s electronic signatures and mobile devices is an exciting opportunity for the company.” says Squillante.
THE TIME IS NOW
Contract packers in regulated industries must demonstrate the proper handling of consumer products via batch records. This can be a tedious and error-prone process if done manually. Faced with short lead times, high SKU proliferation, and growing complexity, contract packers in healthcare and pharmaceuticals are realising the importance of digitising and automating the creation of batch records.
Many systems do a good job of recording transactions, signatures, and electronic records. The weak links, however, are the individual touch points that data passes through as part of the compliance and supervisory process, and those places where data is moved from one system to another. In response, many contract packers and manufacturers are gravitating toward systems that offer digital quality checks and seamless digital sign-offs.
The time has passed when contract packers and manufacturers could survive by clinging to traditional paper-based or home-grown systems. Their environment has become one characterised by short production runs, shrinking lead times, and high SKU proliferation, where automation is needed to stay agile. Software solutions must make compliance quick and easy by providing audit trails, automated batch records, electronic signatures, and a quality control workflow that’s integrated within the production environment. The ability to harness technology to stay agile and fulfill orders on-time, in-full, and without compromising on quality will determine the winners and losers.