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Article | January 31, 2005
Insights into FDA CFR 11 and packaging (sidebar)
Mike Haldane of 3M delivered a presentation entitled “FDA CFR 11 and Packaging” at a conference session at Pack Expo International, held in Chicago in November.
In it he provided an overview of the FDA’s CFR Part 11 guidelines the impact of poor quality the importance of packaging and gaining a return on investment.
Haldane quoted 3M quality consultant Nancy Alcorn with this guideline overview: “The intent of CFR Part 11 is
to ensure data integrity by selling minimum standards for accuracy trustworthiness and reliability of rewards.
“Computerized systems should provide the same degree of confidence as paper systems. The ability to store and retrieve ever-growing quantities of e-data is a challenge for most companies and should be an integral component of any comprehensive CFR Part 11 compliance plan.”
Insights into poor quality
• Companies have incurred millions in FDA fines some in excess of $500 million.
• Approximately 50% of all recalls are due to packaging errors.
Importance of packaging insights
• Consumer safety cannot be compromised by mislabeled products including copy in usage instructions allergen warnings and ingredient statements.
Insights into gaining an ROI
Haldane said “Many pharmaceutical companies have over-the-counter products too.” He explained that consumer packaged goods companies have distinct packaging needs that if managed properly can produce significant results including the following:
• Increased speed to market
• Reduced packaging costs
• Enforced brand standards
• Compliance with retailer mandates
Among his conclusions:
• Life science companies cannot afford to compromise quality in packaging or anything else.
• IT systems that are document based do not address critical packaging issues in life sciences.
• Integrated packaging management provides needed functionality to ensure top quality.
For a detailed look at Haldane’s presentation visit www.pmmi.org/ms/peconf/w16.pdf. —Jim Butschli
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