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Many points during the packaging process pose a risk to product quality and safety. Package design and production risks include material/product interactions, incorrect labeling, incomplete product information, translation mistakes, out-of-specification containers and components, and supply-chain disruptions. Packaging line risks may involve handling that damages the product; stray, damaged, or contaminated product; inaccurate count or fill level; missing components; incorrect components; and poor seal integrity.
“In pharmaceutical packaging processes, there is a risk of creating critical defects,” Shannon Walker, vice-president of Quality H&PC Packaging Americas at Essentra Packaging, told Pharmaceutical Technology. He added, “In some cases, this may lead to a regulatory breach and, more importantly, a patient injury. For example, print defects in product mixes, critical dosages, or usage instructions may change the meaning of statements, creating critical consequences for the patient.” He reports that commonly overlooked risks in product interactions are associated with processing aids and equipment lubricants. If transfer through the packaging material occurs, the medication could be rendered ineffective or even unsafe.
So how can risks be mitigated? Walker says, “ISO 9001 provides basic regulatory guidelines, while PS 9000 is a standard for primary, secondary, and complex packaging materials intended for medicinal purposes. PS 9000 provides complete GMP guidelines and risk assessment requirements to mitigate potential risks” (1, 2). Another tool is the FDA’s Guidance for Industry, Safety Considerations for Product Design to Minimize Medication Errors, published in April 2016 (3).
Software also can play a role in managing risk. Packaging components can be either attribute-driven (e.g., bottle closure torque) or variable-driven (e.g., container wall thickness), notes Walt Murray, CEO of ARC Experts and a member of the Quality and Compliance Consulting services team at MasterControl, who stresses the importance of understanding the difference between the two.
“Either type of data can be analyzed for patterns which present potential risk conditions,” says Murray. “A risk-based analysis should be performed during each of the six interrelated phases of the design control process (requirements and planning, development, verification, transfer, validation and commercial release). A design review should be conducted at the end of each phase. Change control, on the other hand, can be initiated wherever necessary.”
Murray also notes that human factors present the greatest risks. These risks can be minimized or eliminated by automating the label and packaging processes with software. “Everyone needs to understand where the risks lie when a process is not automated. Automation controls the risks associated with human application. This is explicitly spelled out in the new quality standards.”
Controlling risk must extend across the supply chain. Essentra Packaging, a supplier of cartons, labels, leaflets, and blister foils, has established a validated Risk Management System to protect all stakeholders associated with its products and services. Walker says, “Essentra provides a significant, continuous amount of cGMP training to employees.” In addition, “Essentra advocates for paying attention to detail at all levels of the organization.” This philosophy has helped prevent at least one recall. In this case, an experienced press operator, setting up for a run of cartons, noticed the most recent artwork change was for a medication intended for daytime use only. From his previous work with this client, the operator knew the image on the carton matched the capsule intended for nighttime use. So the operator stopped the setup and requested confirmation. It turned out the artwork was incorrect. The operator’s alertness made it possible to correct the artwork before thousands of cartons were produced. Expenses associated with scrapping cartons with the wrong artwork or recalling mispackaged product were averted, and the product’s good name was preserved.
Essentra holds third-party-verified ISO 9001 and PS 9000 certifications for its quality systems and performs business reviews on new projects to ensure quality requirements will be met. Walker reports, “We work to ensure equipment and processes are validated against predefined protocols, to ensure their output is as intended before operations begin. Essentra also has a separate and independent quality assurance organization. This includes offline electronic comparison systems (print verifications), 100% vision inspection on some equipment (print verifications), and 100% identity scanning of materials (to prevent product admixture).”
Essentra’s Risk Management System is complemented by a comprehensive Disaster Recovery Plan, which includes strategies and tactics for rapid communication, the ability to qualify multiple production sites, and plans that cover specialty products, which may include qualification of external service providers. As a result, if a department or site should experience a slowdown or stoppage, production continues.