Hallie Forcinio
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Sometimes it makes sense for a pharmaceutical company to outsource the packaging of one or more products. Some contract packaging
firms also are contract manufacturers that can make the product as well as package it.
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.
In addition to standard bottles or blisters, some contract packagers offer proprietary designs like the unit-dose Snapplicator
from Tapemark. (IMAGE IS COURTESY OF TAPEMARK)
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Most contract packagers also provide other services, including custom designing packages that aid patient compliance, vial
labeling, secondary packaging such as cartoning and kitting, cold-chain, ePedigree, and repackaging. Some firms also assemble
devices such as syringes, and others offer stability testing, microbiology and chemistry laboratory testing, engineering support,
and tooling design and production. Tooling frequently is dedicated to one product and often is owned by the pharmaceutical
company rather than the contract packager. Tooling costs may be assumed by one company or shared by both.
Criteria for selecting a contract packager
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Although outsourcing sometimes seems like an obvious solution, selecting the right partner requires considerable effort and
can take time (see sidebar "Criteria for selecting a contract packager"). Companies can spend as long as 18 months on the
vendor-qualification process. Because many contract packagers that serve the pharmaceutical industry specialize in specific
product and package types, the first step is to identify suppliers with the capability and experience to handle the product
(e.g., solid dose, liquid, parenteral, or aerosol) as well as the desired package (e.g., bottle, blister, wallet, vial, ampul,
pouch, or syringe).
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.
