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By Doug Bartholomew
“The CMO will provide an overall ‘statusing’ of which codes were used, which were not used, and which were for products that were pulled for quality sampling, or where the labels did not come out right and the product was scrapped,” says John Danese, Senior Director of Life Sciences at Oracle Corp., one of the leading ERP vendors.
Despite the apparent benefits, many pharmaceutical companies have been somewhat slow on the uptake to embrace the sharing of various kinds of information with contract suppliers. “I think the bus is about half full, with some pharmaceutical companies yet to get on board,” Danese observes. “For some CMOs, their idea of advanced communications is a fax. There is a broad spectrum of maturity among companies in the way they deal with their partners.”
Looking ahead, Danese believes that in the next few years, the industry will more fully embrace the electronic sharing of product quality information between pharma companies and their outsourcing partners. “The exchanging of quality information electronically is a bit down the road,” he says. “I think we’ll see a larger uptake in the next three to five years.”
In fact, the sharing of quality data has historically been an area where pharma firms have lagged. While most pharmaceutical firms have a CAPA system in place, those systems’ lack of connectedness or integration to larger systems such as ERP has been a serious stumbling block to information-sharing between drug manufacturers and outsourcers. One reason is that CAPA systems often are not connected with other plants or with systems that can measure overall process effectiveness.
Nonetheless, connecting CAPA with ERP promises huge potential benefits. The chief goal is to ensure that everyone who needs to know about — or act upon — production miscue or quality problems, has easy and immediate access to the necessary data. The ability to both trace a batch of material to the source as well as to access all documents associated with it through the production journey can be very helpful in correcting and preventing future occurrences of similar problems.
Compared to the pharmaceutical industry, the high-tech industry is light years ahead in terms of information sharing with contract partners. Of course, outsourcing has long been a way of life for electronics firms, which often have little or no manufacturing of their own, but instead depend on an entire ecosystem of semiconductor foundries, assembly makers, and test providers to handle production. Many high-tech companies outsource logistics and warehousing as well, and some even outsource every aspect of their business.
But in a highly regulated industry like pharmaceuticals, there is an even greater need for information sharing and stronger ties between manufacturer and CMO. “We see pharmaceutical companies sharing quality data both ways, manually and electronically,” says Elaine Schroeder, vice president of sales at Pilgrim Software, a provider of quality and compliance management systems.
From a quality standpoint, OEMs must first certify the supplier through an audit to determine that the contract firm adheres to standard operating procedures and GMPs. For instance, if a packaging non-conformity has been identified at the CMO, the pharmaceutical company may require the outsourcer to report on the problem electronically. “Pharma companies that have a quality management system may require the packager to respond through their supplier portal,” Schroeder says. “But some respond through faxes or other means,” she adds.
“Usually if the pharma company issues a change in supplier materials, they will communicate this through a supplier portal,” Schroeder points out. On the sharing of CAPA data, Schroeder says, “It’s not all that complex to have one CAPA system feed another CAPA system.”
Yet another challenge facing many pharmaceutical firms is, ironically, an internal one — too many versions of the same ERP system that have yet to be consolidated into one. This lack of consistency within an organization inhibits the smooth sharing of data with outsourcers. “We have a well-known medical device company with three versions of SAP that don’t communicate with each other,” Schroeder says. “Another client has more than 60 versions of their call-center software, so they are not even treating their customer complaints in any homogenous way.”
Companies that have a manufacturing execution system (MES) in place have a leg up when it comes to collaborating with contract suppliers, Schroeder explains, because they have more detailed production data already on tap. Certainly in the high-tech industry the use of an MES with web-based access at both the electronics manufacturer and the contract outsourcer provides:
Much of the impetus to adopt these technologies in the pharmaceutical business can be attributed to action on the part of regulatory agencies. “I think the regulatory bodies are providing the push in certain sectors of the industry, such as in the medical device area,” Schroeder says. Device makers are required to do electronic submission of product deficiencies or non-conformances to a regulatory agency, she adds.
PharmaManufacturing.com is the site for knowledge, news and analysis for manufacturing and other professionals working in the pharmaceutical, biopharmaceutical and biotech industries.