Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published January 2000
SPOTLIGHT
Preventing a Recall: How to Select the Right Pharmaceutical Printer
If drug manufacturers want top-quality, hassle-free, and cost-effective printed materials, they should audit potential printers carefully to ensure that their expectations—as well as FDA's requirements—can be met.by Tom Moore, president, California Litho Co. (Chatsworth, CA)
Finding a printer that can meet drug manufacturers' expectations as well as FDA's requirements is no simple task. Drug manufacturers demand that printers meet deadlines and stay within budgets, while FDA focuses on the quality of printed products such as labels, inserts, and product manuals. Ultimately, such quality will mean the difference between a smooth drug product launch and a recall.
A California Litho worker removes a roll of finished labels from a flexographic press.
When searching for a pharmaceutical printer, companies must conduct detailed audits of potential vendors. Not only should auditors ask a multitude of questions, but they should also visit the vendor's facilities and investigate its business practices.
WHY AUDIT?
FDA mandates that manufacturers carefully audit all potential vendors in excruciating, but necessary, detail. A printer's procedures, equipment, documentation practices, and even employee training must be scrutinized.
Before companies begin an audit, they should research the printer. Important issues that should be addressed include:
- What is the printer's track record?
- Are its salespeople known for building long-term relationships?
- Is the printer known for its expertise, dedication to quality, and responsiveness to customers?
- Is the printer capable and willing to handle emergency jobs?
- Does the printer adhere to current good manufacturing practices and to good documentation processes?
DURING AN AUDIT
Most auditing teams spend about eight hours at a pharmaceutical printing plant, but some stay as long as three days. A confident and reputable printer will introduce employees and give auditors the opportunity to talk with workers anywhere in the operation. The following are just some of the questions that auditors should ask:
- Is the printer keeping ahead of the technology curve? Technical innovation is essential in today's marketplace. Pharmaceutical printers should design and build proprietary machinery to match clients' needs rather than accept the limitations of off-the-shelf equipment. For example, at California Litho we had a special job that required assembling and gluing a number of inserts into one stack. There was no machinery available that met our requirements, so we built it.
- Can jobs be handled regardless of whether they're delivered in an envelope full of photos and text; on a Jaz, Zip, Bernoulli, Syquest, or floppy disk; or via modem or an FTP site?
- Are equipment, instruments, machines, and rulers calibrated regularly? Are detailed certification logs maintained in the quality assurance department?
- In addition to FDA's mandated good manufacturing practices, does the printer adhere to ISO 9000 standards and quality assurance procedures? Job flow and traceability should be firmly in place so that the job is constantly monitored at all stages, especially by quality assurance inspectors.
- Does the printer train all employees in a structured environment based on written procedures, in which even new employees learn the same guidelines and operational imperatives?
- Will the printer keep confidential printing aids and files under lock and key for a specified number of years? Do all employees sign confidentiality agreements?
- Does the printer maintain errors and omission (E&O) insurance? One label error on a million packages requires the recall of the entire million. E&O insurance covers the cost of the recall as well as repackaging and redistribution for errors that occur at the printer.
GOOD HOUSEKEEPING
No audit is complete without a tour of the printing facility, which should include a thorough review of its cleanliness and materials acquisition and waste management processes.
Besides maintaining clean workspaces and equipment, the printer should have air dams and doors in place and kept closed to prevent particulate matter and insects from contaminating print jobs. Dirty or spotted labels or inserts can affect the final package's image.
Tom Moore (left) and Ed Bergmann review finished press sheets.
Manufacturers should determine how frequently the printer rotates raw materials such as ink, stock, and pressure-sensitive materials. Monthly rotation is the standard. Also, does the printer follow first-in, first-out (FIFO) procedures to maintain a fresh material supply?
Procedures for notifying customers of a materials change should be in place. For instance, if an adhesive changes from acrylic to solvent or is discontinued and replaced, the new adhesive may have properties that could migrate into the pharmaceutical product. The printer should be prepared to alert customers immediately in order to determine material compatibility.
The pharmaceutical printer should be environmentally conscious, not just to satisfy the EPA, but to remain in good standing in its community. A strong reclamation and recycling program should be in place to handle and dispose of all waste materials, such as paper, adhesives, solvents, ink, and printing overruns.
BUSINESS PRACTICES
During this stage of the audit, drug manufacturers should examine the printer's expansion and growth, as well as its reinvestment into the business through the purchase of new equipment and resources. The auditor should look for computer and digital capabilities such as the ability to manage rapid image conversion via software rather than via old, slow hardware systems.
Employee sentiment about their company, their plant, and their job should also be considered. Does the company have morale-boosting recognition and reward programs in place? Auditors should ask how long most employees have been at the company.
Another auditable criterion is employee training. Does the printer maintain records on the training of every employee in their job function and on the company's procedures? At California Litho, we often send key people to off-site training programs.
Just-in-time ordering practices can also be a good gauge of whether the printer avoids tying up capital that can be better invested in R&D and improved client services.
The printer should control most or all of the printing processes in-house. That way, the printer is not dependent on another company's production schedule or quality control.
Finally, manufacturers should determine the number of shifts that the printer runs. If necessary, the printer should be able to handle emergency staffing over a weekend or round the clock to accommodate a rush job or an emergency reprint.
THE MANUFACTURER'S ROLE
Much of the success of a print job rests with the drug manufacturer. Its planners should build in sufficient lead time to avoid last-minute crunches that can pressure suppliers and rack up extra costs. Also, its planners should determine what current and projected usage will be to possibly take advantage of economies of scale.
Manufacturers should periodically evaluate new printers to establish benchmarks of excellence in service and quality control. The manufacturer will be able to gauge the strengths of its suppliers over time and will be able to utilize the most-capable printers.
Finally, manufacturers should maintain an open exchange with printers in order to obtain advice on materials and design. This is particularly important in the healthcare industry, where materials need to be validated and subjected to stability studies. Such an exchange can eliminate projects that eat up time and costs and cause a lot of frustration.
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