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Software helps SmithKline gain compliance

New software helps SmithKline Beecham comply with FDA GMPs for creating and disseminating packaging specifications. Software permits validation of packaging spec dissemination process, virtually eliminating exposure to compliance violations. Part one of two.
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FILED IN:  Machinery  > Filling/sealing  > Dry filling
     

Corporate packaging departments in all industries face a daily battle to establish and disseminate packaging material specs rapidly and consistently to all in the company who need them. A packaging specification is a written document and/or a drawing that clearly identifies the dimensions volume material and other aspects of a packaging material or container.

In the pharmaceutical industry however it's more than just an inconvenience when different versions of a spec are circulating. That can cause hefty fines from FDA if the offending firm is caught.

For example someone in purchasing might order a quantity of closures from a vendor using say version four of a spec that specifies that the foil induction seal liners inside the caps be unprinted. But a quality assurance inspector in the very same plant may have version five of that same spec-the latest-and it may require that the liner be printed with "Sealed for your protection."

If FDA inspectors were to come into the plant and find such a discrepancy "that is a serious GMP violation" according to Tom Pack packaging design development project manager at SmithKline Beecham. While the offense may seem minor it's the principle-inconsistent paperwork-that's important.

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And at SB that was precisely the problem. The package engineering department would print out hard copy specs and distribute them by fax then mail to quality assurance and purchasing personnel at each plant where they'd be kept on file. Regulatory R&D and other departments also received hard copies for their files. But with specs maintained as paper documents stored in filing cabinets in office corners all across the corporation there was no way to ever guarantee that plants would have the latest specs. That left the company open to the ongoing possibility of compliance headaches something SB sought to reduce.

That's why the firm began a test of electronic document management software to create manage and distribute SB's packaging specifications from its Philadelphia PA headquarters to its North American plants. In four years SB has evolved the system into what it is today a comprehensive system that maintains about 5 documents. The specs are contained in word processing documents for bottles closures labels and leaflets plus other components. In addition CAD drawings of containers and other molded parts are in the system. (Label copy and art aren't included in the system because they're handled via a different system in the company.) The software called NovaManage(TM) from NovaSoft® (Burlington MA) resides along with the data on its own dedicated computer called a server in Philadelphia.

How it works

When specs need changing or new ones must be created the package engineering department at SB's headquarters access NovaManage to make the changes (see sidebar opposite page for details). Then designated personnel at each plant-currently quality assurance and purchasing people-have access to the same system via the company's wide-area network (WAN). A WAN links together a company's various offices and plants via dedicated high-speed data communications links.

"It gives me fast access to the most current packaging specs that I need" confirms Rita Curione. She's the labeling/packaging coordinator compliance auditor for SB's Conshohocken PA plant which manufactures powdered antibiotics. She furnishes her plant's QA inspectors with current specs to compare against incoming packaging components received from vendors.

In the company's Cidra Puerto Rico plant materials purchasing agent Marian Romero checks the system to see whether the specifications for a given packaging component say a plastic closure has changed. If so she can simply print out the revised spec and attach it to the purchase order that she sends to the vendor. The vendor's production department then knows to produce package and ship components according to the latest spec. (SB is considering allowing vendors to access the system eliminating the need to print out hard copies.)

Before it wasn't that easy says Romero. When placing an order "I'd have to get [the spec] out of the filing cabinet and if it was an old spec I'd always have to double-check with Philadelphia to see if there had been any changes."

Currently there are about two dozen users of this system. People in departments such as R&D or regulatory affairs who are not yet connected to the system still maintain their own paper files. For these files the package engineering department prints out and distributes copies as before.

System can be validated

With the NovaManage system SmithKline Beecham has for the first time a system for using packaging specs that has been validated. Validation is a set of procedures or protocols that proves that a given system does what SmithKline Beecham claims it does in the event an FDA inspector comes knocking.

The concept of validation is often associated with packaging equipment. But it can be applied to any procedure or process including a workflow within a company. "We hired an outside consultant that came in and did a complete validation" says Pack "both centrally and in each plant."

While the company says FDA inspectors haven't yet had occasion to audit the package specs during surprise inspections the system is there and validated in the event such an inspection takes place.

Although the software was purchased principally to help with compliance it also eliminates internal headaches caused by packaging materials purchased or inspected using an outdated spec. In the past a discrepancy between purchasing and quality assurance departments at a plant would result in a hold being put on the incoming packaging materials while the discrepancy was checked out with the corporate packaging department.

Depending on how fast Philadelphia responded it could hold up the materials for several hours affecting that plant's production schedule. While the company maintains no statistics on such mishaps Pack says it used to happen several times a year at each plant. Since the software was installed Pack can't recall a single incident where the wrong packaging component was purchased or used due to inconsistent documentation among those departments that have used the software.

Justified through compliance

"Compliance is a nebulous but an extremely important benefit" says Pack. "We haven't really taken the effort to document what the problems were upfront and then say 'Okay the system has done this and that as far as alleviating those problems.' It was never a cost justification issue.

"When I presented this [project] to two VPs in the company their reaction was that this can be justified by compliance alone" says Pack.

The cost of the software varies depending on the number of licenses purchased. SmithKline Beecham paid about $100 for the hardware and software licenses to permit 12 SB employees to access the system concurrently.

The price tag isn't huge by most information technology project standards Pack concludes. "Our philosophy was to start small show success and it will sell itself."

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