Pharmaceutical Commerce - November/December 2011 - (Page 23)
Manufacturing & Packaging
Recalls Stimulate Scrutiny of Quality Assurance in Drug Packaging
By F.J. Quinn
Maintaining product quality and meeting regulatory specifications is a daily challenge for pharma manufacturers, but recent events have shown that the quality requirements do not end as pills or vials come off the production line—they must be extended through all packaging steps, and the packaging itself can be subjected to a comparable level of quality assurance. Recent product recalls show cases of the wrong dosage strength in containers (or, conversely, the wrong labels being applied) mispackaged product, or problems with the cleanliness of the packaging components. The increasing number of outsourcing arrangements between brand owners and contract packagers only add another level of complexity to the communication and coordination required. Vendors say they are taking a hard look at systems controls to ensure their products and all components are protected from contamination and other hazards.
“Companies dedicated to ensuring the quality of their products and packaging are taking steps to ensure such quality, investing in complete quality solutions that include quality planning, quality control, quality assurance and quality improvement,” observes Patricia Santos-Serrao, senior product manager at Master Control (Salt Lake City), a provider of process and document management software. “Implementing a proven quality management system that enforces standards and practices for quality assurance will help improve quality and minimize risk.” Drug packaging is taking center stage as several high-profile drug recalls in 2011 were directly linked to this key component in the manufacturing process. One look no further than Johnson & Johnson (J&J; New Brunswick, NJ), which in the past two years issued more than 25 recalls and led to a highlevel management reorganization. Several recalls were packaging related, drawing attention to the importance of designing quality into manufacturing processes. In September, Qualitest Pharmaceutical had to recall multiple lots of oral contraceptives because the pills—which have a specific 28-day cycle—were rotated within their blister cards, altering the weekly regimen if followed. Last March, Pfizer’s Greenstone generics subsidiary had to recall a production lot where the wrong labels were attached, switching a an antidepressant with a prostate hyperplasia treatment. A year ago, RiteDose Corp. had to recall albuterol vials that had the wrong concentration listed on their labels. The J&J situation served as a reminder about the suitability of drug packaging materials and structures is a integral part of the drug approval process. FDA requires assurance that drugs will be protected against contamination, tampering, spoilage, and physical damage that could impact is characteristics, and makes a review of drug packaging part of the information it examines.
“One of the biggest issues that has occurred in the last 18 months – and even earlier – is the failure of companies to report quality-related issues and customer complaints to K.R. Karu, director of the FDA in an efficient sales, Sparta Systems manner, whether they have occurred in the preor post-market,” says K.R. Karu, industry principal, Sparta Systems (Holmdel, NJ), a provider of enterprise quality and compliance management solutions. “This has caused the agency to tighten its oversight of the industry, enforcing stricter regulations for reporting of quality issues and requiring more extensive collection of data related to these issues.” Improving Quality Assurance Quality assurance is an important part of any complete quality management strategy. These programs can comprise hundreds of different components, including deviation management, supplier quality management, corrective and preventative actions (CAPAs), investigations, and change management. “Each of these functions is critical, and many of the most forward-thinking companies in pharma have taken to automating them within electronic quality management systems,” Karu says. “In most cases, these records are related, so having them in one system instead of silos creates needed transparency.” According to industry members, drug makers are making a concerted effort to enhance quality standards for their manufacturing process, rather than simply reacting to manufacturing incidents. “This is the spirit of Quality by Design initiatives, through which companies design processes to consistently deliver better outcomes,” says Randy Tatlock, customer development manager, Aegis Analytical, a provider of manufacturing and process intelligence software. “Other critical quality components
include understanding a process better over time and monitoring process data to improve process understanding.” In order to verify quality, one must understand the expectation for a product, whether it is safety, durability, or performance. “One must ask, ‘what is expected from this product in order for it to ‘perform as expected,’” notes Master Control’s SantosSerrao. “The second component is ensuring that those responsible for assuring that the standards have been met are trained in what to look for when determining that a product meets those standards.” One of the most important steps being taken to improve quality assurance is centralizing management of an organization’s quality processes, ensuring standards are enforced across global operations and geographical boundaries. The tendency in pharma companies is to have different locations working in their own unique
silos, with disparate processes and ways of managing these processes. “From a quality perspective, this can be, at best, cumbersome and, at worst, devastating when a major issue arises, as they inevitably do,” Sparta Systems’ Karu says. “More and more companies have awoken to the fact that processes should be harmonized across the organization, and managed from a central location, so that issues can be quickly identified and resolved.” Several pharma companies outsource the packaging process, which experts say makes it even more important to work closely with contract partners’ quality teams to capture and share the entire quality review information flow in a collaborative environment. “This helps quality and manufacturing teams gain access to all of the precise and timely quality review information that they need to keep current production on track, or to quickly investigate potential issues uncovered in the quality review process,” explains Brian Daleiden, vice president of marketing at TraceLink (Woburn, MA), developer of the TraceLink Network, an industry-wide supply collaboration network. As the level of outsourced production grows, pharma companies are seeking to maintain the same level of transparency and coordination in external quality review processes as they have within internal production. TraceLink offers a Quality Review service, part of the cloud-based TraceLink Network collaborative supply network platform, which helps pharma companies and their external supply partners connect the virtual quality team into a collaborative environment. “As a result, pharma quality leaders can reduce quality review cycle times by over 20% through improved visibility and tracking from initial review submission to final review closure,” Daleiden says, “reduce manual labor and data entry by over 25% throughout the process, reduce the risk of misinterpretation
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Plotting batch-to-batch mean potency
Aegis’ software tracks variations in product quality (in this case, potency), allowing operators to determine how to reduce variability.
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Table of Contents for the Digital Edition of Pharmaceutical Commerce - November/December 2011
Pharmaceutical Commerce - November/December 2011
Brand Marketing & Communications
Manufacturing & Packaging
Legal & Regulatory
Meetings and Editorial Index
Pharmaceutical Commerce - November/December 2011