Risk in Pharmaceutical Packaging
Shifting the industry from a compliance culture to a Quality culture in pharmaceutical packaging
In 2010, an examination of 16 FDA consent decrees conducted by Jim Prutow and PRTM researchers (a healthcare consultancy practice) found that one decree had stretched on for 21 years and was still in force, while another had been in force for 17 years and counting. This is not unusual: The majority of pharmaceutical manufacturing consent decrees linger, remaining in force with no official closeout. The cost of these federal decrees to the organizations can run from tens to hundreds of millions of dollars. 
Just One Piece of the Risk Puzzle
The numerous risks faced by pharmaceutical packaging manufacturers are not just costly noncompliance decrees, Form 483 letters, and recalls. They range from the broad to the specific: overall inability to manage change, compliance, and risk; business and product continuity in the face of continual package component changes (e.g., resin and film change-outs); staying abreast of new or upgraded FDA packaging guidance and regulations; increased use of contract packaging operations; serialization/track-and-trace technology implementations and lack of standardization; longer and more rigorous package validation testing required for ever-evolving container closure components; reusing “grandfathered” testing methods on new products without validating their efficacy; and lack of visibility for each of these risks at the right level of leadership within an organization.
While risk is an inherent element of the cost of doing business for pharmaceutical manufacturing organizations, taking unnecessary risks due to noncompliance or lack of proper planning and quality controls need not cause a business to shut its doors. And adopting a culture of quality need not stem from the failure of a culture of compliance.
What Does a Quality Culture Look Like?
For one, a Quality culture is “patient-centric.” Patient needs are at the root of all decisions.
This mindset must start at the top.
Mohit Chopra, Senior Manager, Technical Operations, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, shared his organization’s experience:
“We understand what it’s like to live through a consent decree having recently received notification from FDA that all three of our manufacturing facilities are in conformity with applicable laws and regulations. With that, we can also appreciate how important a quality culture mindset is and the importance of leadership alignment to that mindset.” 
Chopra continues, “Within Johnson & Johnson, we live by our ‘Credo’:  the values that help drive our decision making which emphasize putting the needs and well-being of the people we serve first. Our Credo ensures we keep a quality-focused mindset that starts at senior leadership and goes all the way down to the line workers. Without that, many organizations will find themselves in a challenging spot.”
Proper Structures and Formal Programs
While quality-focused organizations have proper structures and formal programs in place for risk management, Chopra acknowledges that most organizations do not have a formal risk-management program. 
Quality-centric businesses proactively develop and implement formal risk-management, review, and approval processes. These initiatives include furnishing the proper tools to standardize the risk-management program across the organization, as well as providing proper Governance involving the right level of leadership, “all of which have been strengthened and re-emphasized during the McNeil Consent Decree,” acknowledges Chopra. 
Additionally, quality-focused organizations implement strategic component procurement and qualification programs, corporate standards on serialization and track-and-trace technologies,  and more reliable, quantitative package-integrity testing methods that are part of an ongoing product development process. 
Quality-centric businesses have the right level of leadership involvement in internal governance; they also participate in cross-industry bodies, such as ISPE. “Participation in ISPE or other industry bodies that inculcate these collaborative behaviors across the industry drives that culture,” says Chopra.
“ISPE has been doing good work,” he continues, “especially with the last few annual conferences where there were a lot of workshops around risk management. Education sessions and collaboration with FDA will be the best mitigation to bring Industry to the right level of understanding. It creates the awareness around the behavior and the required Governance structure that needs to be in place.” 
Adoption of USP Chapter <1207>
Quality-focused organizations follow the recommended best practices in package integrity testing put forth in the extensive rewrite of the US Pharmacopoeia general chapter <1207>, “Sterile Product Package—Integrity Evaluation.”
The types of testing methods that are now included in the chapter are largely nondestructive and can be used on the product package intended for distribution. While the tests that are described provide a lot more data, Dana Guazzo, founder and president of RxPax, who headed the panel to revise <1207>, notes, “They represent a big shift in current thinking.” 
Another conceptual shift stressed in chapter <1207> is package integrity testing as an ongoing process that starts in package development and continues for the life of the product. 
Ask the Right Questions
Last, but not least, quality-focused sites ask the right questions—up front.
Asking the right questions pertains to all elements of pharmaceutical product packaging, from identifying where in the world products will be sold, and identifying associated packaging regulations; to strategic sourcing and procurement of package components; to implementing the soundest technology solutions for package production and testing; to determining the most appropriate package testing methodologies based on product-package systems.
In speaking about selecting the proper testing methodology, Oliver Stauffer, vice president and chief operating officer for PTI Packaging Technologies & Inspection, states, “It will require that companies have a thorough understanding of their product, the risks associated with that product, and what needs to be done to protect that product.”  One could extrapolate that advice to all areas of pharmaceutical package manufacturing.
Having a formal program in place enables businesses to ask the questions that identify what elements need to be considered as part of the risk. This ensures proper boundaries around risk-management processes and help keep business “risk creep” at bay. Chopra asserts, “What determines your testing should solely be based on the change and the risk from the process perspective and not any other element that doesn’t involve the actual process and the risk to the product.” 
The Value of Quality Culture
Speaking to the cost of doing business versus embracing a quality culture, Chopra acknowledges, “The change from a ‘reactive’ Quality mindset to ‘Quality as a competitive advantage’ can drive a top-down Quality culture. In the long run, you always see that better quality sustains longer duration and ultimately pays off.” 
To learn more about risk in packaging, be sure to attend the Pharma EXPO Conference 28–30 September 2015 in Las Vegas, Nevada, USA.
 Fierce Pharma Manufacturing. “Pharma Manufacturing Consent Decrees: 16 Black Holes,” 19 October 2010. http://www.fiercepharmamanufacturing.com/story/woodcock-says-fda-will-keep-new-plant-quality-grades-secret/2015-08-27.
 Chopra, Mohit, senior manager–technical operations, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, interview 27 August 2015.
 Gladd, Trisha. “USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices to Avoid Destructive, Unreliable Integrity Testing” Pharmaceutical Online, 1 October 2014. http://www.pharmaceuticalonline.com/doc/usp-general-chapter-revisions-industry-experts-offer-best-practices-to-avoid-destructive-unreliable-integrity-testing-0001.
 Stauffer, Oliver, vice president and chief operating officer, PTI Packaging Technologies & Inspection, interview 25 August 2015.