Outsourcing packaging operations can expedite product launches, accommodate surges in demand or volume growth, provide access to packaging formats that are unavailable in house, locate packaging closer to the market where the product will be sold, and reduce the expenses related to installing and running a packaging line.
One resource that can help identify potential suppliers is the Contract Packaging Association (Naperville, IL). Its website ( http://www.contractpackaging.org/) offers advice about choosing and hiring a contract packager and provides a directory of members that's searchable by criteria such as types of products filled, packaging process, and location.
"Quality and reliability are critical in selecting a supplier," says Aileen Ruff, group product manager for commercial packaging at Catalent Pharma Solutions (Somerset, NJ), which handles various product types and package formats. "Suppliers should also have extensive experience operating under the most stringent regulatory requirements [and] a proven record of success delivering products on time to desired specifications."
Like pharmaceutical manufacturers, contract packagers follow current good manufacturing practices (CGMPs). They also are regularly audited by the US Food and Drug Administration, as well as by customers and other organizations. "We have standard operating procedures for everything we do," says Joe Luke, vice-president of sales and marketing at Reed-Lane (Wayne, NJ), which primarily packages solid dosage forms in bottles, travel-size vials, blisters and pouches. To maintain proper control, "all printed materials are kept in a locked area and must be reconciled as part of the final batch record," he says.
"We can't close a master batch record or ship without a final reconciliation," agrees Paul Dupont, director of business development at Ropack (Montréal). His company specializes in stick packs and products that must be packaged in low relative humidity conditions.
Despite stringent adherence to CGMPs, due diligence is crucial when selecting a contract packaging partner. "Visit the contract packager's operation, walk around the plant, meet the people, check out standard operating procedures. You have to feel comfortable with the people," advises Luke.
Companies seeking a contract packager should perform a quality audit and risk assessment. The prospective supplier's history, customer references, and finances should be reviewed.
Personnel also should examine any Form 483 citations describing CGMP compliance deficiencies that FDA inspectors have observed at a given contract packager. "Not having any [recent] 483s is definitely a positive," says Luke. However, the existence of a 483 shouldn't necessarily be a deal breaker. "It's important to know what the 483 was for and how the problem cited was addressed," he explains.
Steve Larsen, national sales manager for Tapemark (West Saint Paul, MN), a contract manufacturer of transdermal patches, agrees that the existence of a 483 shouldn't be a disqualifier. However, "a series of 483s on the same topic should be a concern," he says.
Once due diligence has been completed, lead times vary, but can be as little as four weeks. Project turnaround will take longer if stability tests must be performed, packaging components must be specified and ordered, tooling is needed, or the package configuration or artwork changes after the project gets underway.