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Agnes Shanley is senior editor of Pharmaceutical Technology.
At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.
At the 2019 INTERPHEX conference and exposition in New York City on April 2–4, PDA sponsored a number of conference programs focused on key initiatives, including a special roundtable, “Data Integrity Across the Enterprise”. As speaker Kir Henrici, managing director of the Henrici Group, noted on that program, the pharmaceutical industry needs a data integrity strategy to match its move to Pharma 4.0. This “Data Integrity 4.0” strategy, she said, will develop a framework for matching IT and data integrity rules, establish data governance, and allow companies to merge data governance with experts in various areas.
Among the key issues that pharma companies will need to strengthen include:
An important step, she said, will be creating multifunctional data governance teams to bring different perspectives to this effort, and facilitate communication between industry and regulators. This spadework will be required if companies are to gain the most from artificial intelligence (AI), she said, mentioning that FDA approved 12 AI algorithms in 2018. “AI offers a benefit by sweeping through billions of bits of data, but it will also be learning and recording how data are currently being used,” she said, adding that “…it is important to understand what patterns it will use and how they could be skewing the data.”
Facilitating the discussion and debate required is an important initiative for PDA, which published guidance on data integrity in the laboratory in 2018, and now plans to finalize guidance documents for data integrity in manufacturing in the third quarter, and data integrity for quality systems in the fourth quarter of 2019. Pharmaceutical Technology asked PDA’s CEO, Richard Johnson to discuss PDA’s plans for data integrity and other important initiatives. Here is some of what he had to say during the conference and exposition.
PharmTech: What progress has PDA made in articulating best practices and a path forward for pharmaceutical data integrity?
Johnson: We have published guidance on data integrity in the laboratory and are finalizing other guidance [documents] that address data integrity in pharmaceutical manufacturing and quality management. We are also preparing for the 2019 PDA-FDA workshop.
PDA’s big data task force is working on use of big data in manufacturing, and strives to connect data integrity activity to the field of big data. It’s a new paradigm for the pharmaceutical industry, as companies move toward Pharma 4.0 and the problem will be getting access to, and making maximum use of, the huge volumes of data that are being generated at pharma companies every day. This will require connecting different IT systems and deciding what to do with all the data, and solving other problems as well.
PharmTech: Where will AI fit in?
Johnson: There is increasing interest in using AI to process and get information from different data via algorithms, and to draw connections between individual data points. Data will need to be safe and secure, and will need to be relevant.
PharmTech: What other plant-floor type applications could we see in the future?
Johnson: Operational metrics could use big data. Predictive maintenance is another potential application that is attracting more pharmaceutical companies. Equipment downtime costs a significant amount of money. Predictive packages could be used, for example, to design programs that would prevent plant and line shutdowns, maximize uptime and minimize batch rejections, all by applying basic operational excellence concepts. A lot of IT professionals working within the industry are very active in this area, and the Software Engineering Institute has developed a model for manufacturing
PharmTech: You mentioned operational excellence. Is PDA working on any special projects in this area?
Johnson: Elements of operational excellence have already become standard industry practice, even if pharmaceutical companies aren’t talking all that much about it. We are partnering with the University of St. Gallen in Switzerland, correlating data that they have developed with our own data, to draw conclusions about pharma’s quality culture.
So far, what we have seen is surprising. For years we had heard that the pharmaceutical industry was behind other industries in operational excellence, but St Gallen’s research, which looked into quality cultures of both pharma and non-pharma companies, has found that some pharma companies’ quality cultures are superior to those of non-pharma companies in some ways. Forward-thinking companies are applying operational excellence concepts to quality, training, and regulatory compliance.
PharmTech: US regulators have been working on new quality metrics, but also discussing the importance of companies having a “quality culture.” Do you see that driving any future guidance?
Johnson: FDA, MHRA, and other agencies are very interested in the concept of quality metrics and quality culture, and the two areas are overlapping. FDA has been working on its quality metrics program but is interested in bringing more of a quality culture approach, especially to pharmaceutical facility inspections.
PharmTech: What work has been going on with post-approval changes, and facilitating pharma companies’ ability to harness innovation and improve their plants’ performance?
Johnson: PDA has an active group working with heads of quality to develop a set of best practices. This group has met with FDA and will be having another meeting with FDA in December  from which a technical report and case studies will be developed. At this point, we are discussing the project with regulators to agree on basic principles. So far, some examples have been selected for the report and case studies, including excipient change and compendial method change, that require prior approval filings.
The whole subject has become a huge nightmare for pharma companies because they cannot implement changes in different parts of the world at the same time. On an individual level, regulators are supportive of harmonizing requirements and addressing the need for facilitating post-approval changes. We are now discussing the possibility of offering training in PACs with the World Bank, which sponsors the World Health Organization.
PharmTech: How are PDA’s efforts progressing in aging facilities, since this challenge continues to drive shortages of key commodity pharmaceuticals?
Johnson: A group of manufacturing leaders on PDA’s manufacturing science and operational program steering committee is continuing to work on this and is updating a technical report on isolator technology. Some of PDA’s data integrity efforts intersect with this work, e.g., by looking at how to implement the best principles at new sites, and at facilities that are changing from manual or paper-based to electronic data management, and to advocate for modernization. PDA has also developed a drug shortage guidance document that companies can use at no charge to help them analyze potential for manufacturing-related shortages.
We had been working with European Medicines Agency to develop more guidance on drug shortages, but the current Brexit strategy has changed some of these plans for now.
PharmTech: What work is PDA doing internationally?
Johnson: In February 2019, we set up a business unit in Asia Pacific, in Singapore, to support PDA’s efforts in the Pacific Rim. This includes three conferences plus courses. We already have branches in Japan, Taiwan, and South Korea. We are expanding the number of training courses we offer in that region. For example, 20 courses are now offered in India.
We see outreach to this area as crucial, given the fact that more people work in pharma in India than in the US and Europe combined. And the same is true of China.
In other areas, we are enhancing the training available to professionals in Brazil and translating more PDA guidance documents into Japanese, some Chinese, Spanish, and Portuguese.
On the technical side, we are focused on aseptic processing. As the draft of Annex I is revised in Europe, it will be one of the industry’s biggest regulatory changes in a decade.
PDA is also examining the challenges posed by cell and gene therapy, and getting into standards development. Last year, we became American National Standards Institute-accredited and our standards development efforts will initially focus on four areas: