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Validation continues to challenge packagers

Respondents address the issue in an exclusive survey. A survey completed in January asked respondents to identify the most important among five healthcare packaging-related issues for their company in the next year or two; 37% of packagers cited validation. Counterfeiting and good manufacturing practices (GMPs) each received 17% of the "vote," followed by FDA regulations at 12%, and outsourcing at 7%. Among the 10% who selected "other," the most frequently mentioned topics were package innovation, and offshore regulations. Here's a sampling of some of the responses regarding validation:

• "The major challenges are implementing technology-driven packaging processes [validation], equipment and materials at an acceptable cost to meet the regulatory demands and quality upgrades," said a respondent from a firm that makes pharmaceuticals, as well as lyophilized products.
• "We are moving to a global database for all outsourced packaging vendors, [with] access via the Internet, running off our MRP system," said a medical device manufacturer. "Validation [of] all external locations will provide challenges."
• A respondent from a maker of medical devices and liquid pharmaceuticals said, "We are a small manufacturer. Usually we build our own test equipment in-house. That equipment is hard to validate."
• "Patient safety and drug efficacy are the two things that drive the GMPs. Thus the validation testing that confirms those concerns [needs to be] addressed," expressed a representative with a pharmaceutical company. "The big challenge is translating those concerns into effective protocols. [Often times] a lot of other unrelated testing tends to get put into the protocol, taking the focus off the GMP concerns."
• "Material variations from suppliers" was a worry brought up by a respondent from a company that produces pharmaceuticals and medical devices. He added that validation requires "significant resources to prepare documents and conduct testing." He also expressed concern with "changing regulatory requirements and expectations, and lack of global harmonization."
• A respondent from a medical device, pharmaceutical and biopharmaceutical maker admitted, "Keeping validation meaningful and technically correct in methodology and results is the largest challenge due to a poor history of
packaging component and material knowledge in-house."
• A medical device manufacturing pro lamented about "the resources needed to perform validation, and the amount of packaging [that would] be destroyed."
• "Implementation of RFID tags on materials to exclude mix-ups at the start of packaging is a major challenge. Validation of this process (it must be 100 percent effective) is required," said a solid-dose pharmaceutical company respondent.

--By Jim Butschli, Editor
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