The FDA and PDA, Patient Safety Guardians

PDA is working with FDA through a cooperative agreement on the Compounding Quality Center of Excellence to provide training to outsourcing facilities to help improve the quality of compounded drugs. PDA’s long-standing expertise in providing training to the pharmaceutical industry will be advantageous in expanding the Center of Excellence training program. The partnership aligns with PDA’s mission to advance science and regulation for members, as well as non-members, to better serve patients. Through the Center of Excellence, PDA and FDA are working with the drug compounding community to enhance quality and have a positive impact on patient care.??

PDA’s partnership with the Center of Excellence is to develop and deliver training courses to support outsourcing facilities in providing quality drugs for patients who need them. The Center of Excellence, among other program areas, offers training courses focused on building an understanding of all aspects of Current Good Manufacturing Practice (CGMP) including aseptic processing. The training courses also focus on the overarching quality management system to ensure participants adopt a culture of quality that puts patient safety first.??

Our combined commitment to quality?

FDA has a longstanding commitment to drug quality. Dr. Ian Deveau , who serves as the deputy director for quality in the FDA/CDER/Office of Compliance/Office of Compounding Quality and Compliance, oversees the Center of Excellence and advises on the training courses and content.???

“I encourage outsourcing facilities to engage with FDA and PDA through the Center of Excellence. These training courses have been designed to meet your needs and enhance your ability to serve your end user – the patients who need compounded drugs,” says Ian.???

Patient safety is our north star?

When you consider the weight of the responsibility of keeping patients safe, you always want leadership that never loses sight of that mission.??

We all play a critical role to ensure that only quality compounded drugs reach patients and to protect patients from poor quality compounded drugs. This is a shared responsibility among outsourcing facilities who are making compounded drugs, FDA through its oversight and others, like PDA, working to educate industry and share best practices.?

“A culture of quality is a win-win,” says Ian. “A robust quality management program is better for business and, most importantly, better for patient safety. When there’s a steadfast commitment to quality vigilance, everyone wins.”?

He says professionals in this field are faced with making sterile products in an environment awash with microbes in the trillions. It requires continuous attention and commitment combined with the technical knowledge to make that happen. Simply stated, producing sterile drugs is ultimately a high-risk job. Yet, when it comes to patient safety, there is no room for error.??

Quality culture?

“Within the industry or a particular facility, the quality assurance unit is ultimately the guardrail in that facility. The agency has a role in placing limits, but it is the quality unit’s and ultimately the facility’s responsibility to make sure they represent the interests and voice of the end user, the patient. Our role at FDA is to provide the right guidance and oversight to help enforce this for patient safety,” says Ian.???

These training courses provide a clear understanding of how all aspects of sterile compounding production are interrelated. A part of a strong quality culture is when every individual in the process understands his or her role and responsibility and interrelate with everyone else. The work is achieved through a collective, collaborative effort within a facility with all levels of staff having a voice and input in the process. The Center of Excellence training courses are created to promote an environment based in a quality culture, overcoming the typical silo mindset thinking and embracing collaborative problem-solving.??

Building a quality culture is ultimately achieved through a top-down, bottom-up approach. It starts at the top of the organization with the CEO, senior leadership and management teams providing adequate oversight, resources, empowerment, advocacy and encouragement to enable line-level staff to be able to speak up, identify and mitigate risks. This approach ultimately ensures outsourcing facilities produce quality compounded drugs for the patients you serve.???

Looking to the future?

“The future will bring new technologies, the needs of the patient will change, and medical advancements will evolve,” says Ian. As this occurs, we need to do everything we can to take transformative steps to prevent patient harm. Your participation in these training courses is a great step in promoting quality, and Ian urges everyone to look for new opportunities to enhance compounding practices and commit to implementing robust quality practices.?

FDA appreciates its collaboration with PDA for its pivotal role in the Center of Excellence training courses.??