Richard M. Johnson is president of the Parenteral Drug Association.

Richard M. Johnson

	I have been involved in the healthcare products industry for all of my professional life, more than 35 years in varied environments and operations in the United States, Europe, Asia, Australia, and Latin America. During that time, I have seen many changes in the manufacture and control of pharmaceutical and biopharmaceutical products. 

Some changes are inherent in the newer products that have been introduced, but many of these changes have been technological: the advent of computerized systems; instruments and sensors to monitor and control machine function; increasingly sophisticated software; and the ability to communicate data via wire and wirelessly around the world. 

	One of the ways that we have applied these technologies is through the generation of volumes of data that were previously either not accessible or impractical to analyze. It is through the generation of data, and the review of these data by knowledgeable persons in comparison to specifications and standards, that we base our quality decisions. Even the least sophisticated operation today employs electronic systems for many applications: inventory control, analytical data capture and analysis, equipment control, and reporting.  As these changes have occurred, there have been evolving changes in the regulatory focus--from quality control and an emphasis on testing quality--to quality assurance and process validation--to quality by design and lifecycle management.


	But while electronic systems are becoming more widely used and generating ever larger amounts of data, it is also true that all of our operations depend on a network of people to perform a wide variety of functions, from material manufacturing, transportation, finished-product manufacturing, testing, distribution, regulatory filings, and controlling records that involve a combination of both electronic and paper-based records.


	In addition, there is a growing globalization of the business and the dependence on partners from -outside the primary organization. Activities that used to be done within a single organization are more likely today to include a network of separate organizations that are interdependent on goods, services, and data exchange. Many of the healthcare products used by patients around the world involve manufacturers and suppliers from multiple continents who communicate in multiple languages. 


	A basic principle of assuring the quality of healthcare products is the review of data. Industry experts review data from their partners; independent quality groups review manufacturing and testing data; and regulators who are responsible for monitoring the products for the public review all data. The accuracy, trustworthiness, and the integrity of that data must not be in question, or all of the checks and balances, control measures, and quality agreements will not be effective. This is equally true of the traditional paper-based records and electronic data. 

	The recent emphasis on data integrity is not new, but it has never been more crucial. This principle should remind us of a basic tenet: All relationships are based on trust and evidence. If the integrity of one’s data is questionable, the loss of trust will have severe consequences. We should all be committed to reinforcing the importance of data integrity.

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	When referring to this article, please cite it as R.M. Johnson, "Data Integrity: Getting Back to Basics," 

Articles

Ensuring data integrity involves effort on an individual and global basis.

Data Integrity: Getting Back to Basics

The Parenteral Drug Association (PDA) focuses on connecting people, science, and regulation. For more than 60 years, PDA members have been active in responding to and driving implementation of global regulatory initiatives. Association members did not recently discover what the “c” in cGMP stands for; they have been actively defining and shaping it for many years. Nowhere is this commitment and energy more in evidence than at the PDA/FDA Joint Regulatory Conference, which will be held for the 23rd year, on Sept. 16-18 in Washington, D.C. 

An objecive indentified in PDA’s Strategic Plan—Regulation—states: “Our regulatory activities are scientifically and technically focused, and current information is communicated to our members.” The organization supports this strategy with several criteria, including the provision of science- and technology-based input on regulations and guidelines related to PDA strategic areas, utilizing PDA’s volunteer and membership base. The organization maintains valuable and effective relationships with global regulators and educates members on current expectations.

Over the past six decades, PDA members have commented on every key cGMP regulation and guidance. PDA has hosted joint conferences with regulators, provided specialized training to regulatory authorities, and included regulatory officials in its processes for developing technical reports. This activity led to the creation of the PDA/FDA Joint Regulatory Conference nearly 25 years ago. It did not take long for this conference to become one of the most important annual events hosted by PDA for its members. Overall meeting attendance and the number of attendees and speakers representing not just FDA, but regulatory bodies from around the world has grown each year. 

The 2013 PDA/FDA Joint Regulatory Conference: Driving Quality and Compliance throughout the Product Life Cycle in a Global Regulatory Environment, opens with a business imperative. Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research (CDER) will provide regulatory perspective, and Daniel Kraft, MD, executive director of FutureMed, will provide industry insight on the status of quality systems, quality by design, and drug shortages. The conference will conclude with information about FDA initiatives from representatives of CDER, the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA).

 The conference offers four plenary sessions:
  • 	The Quality Culture & Partners session explores ways to implement quality culture, how the culture impacts the effectiveness of a quality system, and highlights significant indicators of a weak quality culture.
  • 	In the Understanding Good Manufacturing Practices session, speakers will 
  discuss how safety and efficacy is assured by routine adherence to the quality assurance and manufacturing control practices embodied in the GMPs. 
  • 	A Patient’s Perspective is designed to offer insight from a patient--someone who can help drug development professionals focus on their mission by expressing how drug products have helped save lives.
• 	In the Compliance Update session, compliance directors at each FDA center will report on current topics in the compliance arena.

The 2013 PDA/FDA Improving Investigations Workshop follows the conference on Sept. 18-19. Here, FDA specialists and industry experts discuss the root causes of poor investigations. As you may know, these are among the top inspection observations globally. Finally, extend your learning in one of six courses offered by PDA’s Training and Research Institute.

These activities exemplify PDA’s tireless focus on “Connecting People, Science, and Regulation.”

Richard Johnson is president of the Parenteral Drug Association (PDA).

PDA/FDA regulatory conference promotes a commitment to quality.

Connecting People, Science, and Regulation

PDA has thousands of members who spend a great deal of their time tracking regulatory requirements around the world and communicating with regulators about quality and GMP issues. Over PDA's long history, the membership has found that coming together through the association to participate in the regulatory process was an effective and preferable way of communicating with the regulatory bodies. Many members volunteer to serve on committees to develop comments. 

This regulatory activity is embodied in the third element of PDA's 2010 Strategic Plan, which states: "REGULATION— Our regulatory activities are scientifically and technically focused, and current information is communicated to our members." This is further defined with four criteria, the first two calling for: 1) the provision of science- and technology-based input on regulations and guidelines related to PDA strategic areas, utilizing PDA's volunteer and membership base, and; 2) maintaining valuable and effective relationships with global regulators, and educate members on current expectations. 

Over the past two decades, PDA's membership has moved beyond just commenting on new regulations and guidance. Through hard work and careful planning, PDA has been able to host joint conferences with regulators, provide specialized training to regulatory authorities, and include regulatory officials in its processes for developing technical reports. These closer forms of cooperation all started with PDA's involvement with the US FDA regulatory process, which led to the creation of the PDA/FDA Joint Regulatory Conference nearly a quarter of a century ago.  

It did not take long for this conference to become one of the most important annual events hosted by PDA for its membership. Attendance at the meeting grows each year, as does the number of attendees and speakers representing not just FDA, but regulatory bodies from around the world. 

Over the years, the PDA/FDA Joint Regulatory Conference has focused on key topics important to the agency and the industry, including aseptic processing, GMPs for the 21

  Century, ICH topics, and supply chain. This year's event is no different with the focus on implementing and advancing a sustainable global quality culture. Sessions have been tailored so attendees receive updates on global regulatory strategies from speakers representing  FDA and other regulatory bodies and practical take-home strategies on how to meet the regulatory challenges from industry speakers. Following the meeting, the PDA Training and Research Institute will host a number of courses on similar topics for those who need to drill deeper. 

A highlight of the 2012 PDA/FDA Conference is the post-conference workshop, Responsibilities of Executive Management (Operations and Quality)—Implementing the Principles of ICH Q10 2012 PDA/FDA Pharmaceutical Quality Systems. This event is designed to provide senior management and operations personnel an understanding of the framework established by ICH Q10 for the creation of an efficient and robust quality system that meets regulatory expectations around the world. 

In recent years, PDA and FDA have increased the number of cosponsored events held annually to provide more focused attention to hot-button issues like supply chain and pharmaceutical glass quality.  The hard work and outreach of PDA's European members has formed bridges with regulators throughout Europe as well, and the formation of the European equivalent to the PDA/FDA Joint Regulatory Conference—the PDA/EMA Conference, which has been held approximately every other year since 2005. It will be held next in December 2012. 

Over the last decade, PDA's focus has been on building relationships with regulators throughout the world to meet the needs of our members globally. We held a PIC/S workshop earlier this year and have had meetings and trainings with regulators from Japan, Kazakhstan, Russia, and many others.  

It is these activities that exemplify the membership's tireless focus on "Connecting People, Science and Regulation."			

 is president of the Parenteral Drug Association (PDA).			

PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.

Joint Regulatory Conferences: The Ultimate Connection

The year 2012 will be challenging for the pharmaceutical industry. The marketplace is shifting, bringing unique challenges to manage and explore. Exciting advancements like new drug discoveries and therapies, the increasing importance of biotechnology, growing global demands for better healthcare, and the changing demographics of our societies are taking their place at the global table. At the same time, there is a confluence of economic, political, and regulatory changes influencing business models and mandating new and innovative practices. Some key drivers that our industry is facing include:  									

increasingly complex supply chains and outsourcing models

the rising importance of emerging biopharmaceutical markets. 

As a leading nonprofit association, the Parenteral Drug Association (PDA) and its Board of Directors have been hard at work implementing a strategic plan that will guide the association forward. PDA will continue to focus on "Connecting People, Science, and Regulation" in an industry where "change" is the hallmark of our future. Specifically, the association plans to: focus resources to deliver more PDA technical reports, technical surveys, and guidance; continue signature meetings such as our annual PDA/FDA Joint Regulatory Conference (September 2012); introduce new "hot topic" conferences and workshops on subjects such as glass quality; expand global training activities (60 are currently offered worldwide); and expand synergy to work with global regulatory agencies to enhance pharmaceutical science and advance patient healthcare. 

The 66th PDA Annual Meeting, Apr. 16–18, 2012, in Phoenix, AZ, will focus on many of these themes. Industry and regulatory speakers will present on "Manufacturing Innovation: Achieving Excellence in Sterile and Emerging Biopharmaceutical Technology." Major educational tracks include: Innovation and Productivity in Large Scale Manufacturing; Personalized Medicine/Cellular Therapeutics; and Control Strategies for Biopharmaceuticals. The conference will also offer training courses on Reprocessing of Biopharmaceuticals; Recommended Practices for Manual Aseptic Processes; Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology Manufacturing Operations; Process Simulation Testing for Aseptically Filled Products; and several others.  

The industry business drivers noted above will impact how we work and interact. The confluence of science, technology, and regulation will provide our industry with the guidance to move forward, improve patient healthcare, and create future business models needed to survive. I look forward to your feedback, and would like the opportunity to welcome you to our community. 

 is president of the Parenteral Drug Association (PDA), 

The confluence of science, technology, and regulation can provide path forward.