Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp

Ask the Expert: Questions about Real-World Evidence and Supply Chain Security

The lifecycle of a drug product doesn’t end once the drug is put on the market. It extends beyond, where real-world evidence from patient use of the product provides data that are often relied on in the continued safety testing of drugs or in the development of new drug products.

“Real-world evidence is part of the pharmacovigilance activities, and these are obviously mandatory for all marketed medicines,” explains Siegfried Schmitt, vice president, Technical, at Parexel. “Real-world evidence collation wasn't really required in the past, but it is now. And, in my opinion, it's very likely to stay, given the benefits that real-world evidence delivers. And so, therefore, the real-world evidence for the product must be gathered for as long as you keep the product on the market.”

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, goes on to explain that data about a product must be collected for the product’s lifetime, because of the potential for unknown side effects once used by patients. “You get indications or side effects, [when] you are in the clinical trials. But then once you open it up to the greater population, and everybody can take the medicine, you get more side effects, because it's going to affect everyone differently.”

What kind of supply chain problems can occur during the transportation of pharmaceutical products?

“We are not talking about a breakdown necessarily,” Schmitt says. “We are talking about facts like we heard of from the news, where, say, in the United States, a whole truck [of product] vanished into thin air. They stole a complete truck. They didn’t just break into a truck and steal something. There are some ports in Europe where you should never, ever transport pharmaceuticals through; they get stolen by default. A lane risk assessment is a necessity to understand ‘how can you transport safely, securely? Where should you, for example, stop your truck overnight? Is it illuminated? Is it secured? Is it just in the backyard of a motel?’”

Click the video above to watch Sue and Siegfried answer the following questions:

My company just launched a novel, small-molecule drug into the market. For how long do we need to gather real-world evidence to monitor its safety and efficacy?

My company is investigating options for a novel cell therapy for the oncology market. How can we leverage real-world evidence from our own research and from post-market drugs already on the market to choose which direction to go in?

We are a drug product manufacturer, and we take supply chain security very seriously. As part of our internal assessment, we have identified transportation as a critical element of the supply chain. We use several third parties for the transport of our goods. What security aspects should we address?

Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Siegfried Schmitt, PhD, vice president, Technical, Parexel

Siegfried Schmitt is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.

Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

Q. What is a contamination control strategy (CCS) and how does it support sustainable compliance and continuous improvement?

 A CCS is required in pharmaceutical manufacturing to ensure product safety, regulatory compliance, and efficient operations. The updated EudraLex, Volume 4, Annex 1 (1) mandates a CCS for sterile manufacturing in the European Union, aligning with similar FDA requirements
(2, 3) in the United States, as well as International Council for Harmonisation (ICH) Q9 Quality Risk Management (4) and ICH Q10 Pharmaceutical Quality System (5) guidelines.

A review of FDA 483s and FDA Complete Response Letters (CRLs) highlights areas for improvement in pharmaceutical manufacturing. Citations have been issued for deficiencies related to microbial contamination, environmental monitoring, and aseptic practices. Addressing these observations is required for drug approvals and to strengthen a CCS.

A CCS is a holistic approach to minimizing contamination by evaluating good manufacturing practices (GMPs). A CCS provides a proactive method for identifying, controlling, and scientifically evaluating quality risks designed to reduce contamination and enhance product safety and quality.

Elements of a CCS include the following (6):

Monitoring controls—personnel, in-process, materials, environmental, utilities, and pest controls

Validation controls—qualification/requalification of personnel, process, analytical methods, facility, utilities, and equipment

Contamination controls—personnel training, hygiene and gowning, process design, vendor material, consumable containers, equipment design, cleaning and sanitization

Quality risk management and risk assessment identify potential contamination sources and assess their impact on product quality and safety

Scientific and technical knowledge to prevent contamination

Personnel management to empower personnel through training. Staff education, awareness, and skills play a crucial role in maintaining contamination control.

A strong CCS serves as an invaluable quality tool, ensuring regulatory compliance while safeguarding product quality, safety, and enhancing the company’s reputation. Let’s embrace its power!

Q. Why is a risk assessment required for a CCS?

Conducting a risk assessment is critical for a successful CCS. It helps to proactively identify contamination sources and their effects, enabling implementation of targeted preventative measures that safeguard both products and the well-being of patients.

Identify hazards and risks before they turn into real problems.

Prioritize control measures based on the severity and likelihood of each risk to enable the allocation of resources to the areas vulnerable to contamination.

Regulatory compliance and a commitment to product quality and safety are essential for meeting regulatory standards in our industry.

Fostering continuous improvement by gathering insights, streamlining processes, and embracing innovative technologies. A proactive approach reduces risks and drives growth. This approach enables us to maintain control at every stage of the product lifecycle.

Encouraging a culture of safety that involves cross-functional team members in the risk assessment process. This approach helps everyone understand and take responsibility for contamination control.

A robust CCS begins with a risk assessment. By proactively identifying and addressing contamination risks, we improve product quality, prioritize patient safety, and confidently meet regulatory standards.

EudraLex–Volume 4–Good Manufacturing Practice (GMP) Guidelines

: Annex 1–Manufacture of Sterile Medicinal Products (2022 revision).

 Title 21, Parts 201 and 211. Current Good Manufacturing Practice for Drugs. 2023.

Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing

Chakraborty, S. and Baseman, H. Contamination Control Strategies: A Path for Quality and Safety. 

, May 8, 2022, pda.org/pda-letter-portal/home/full-article/contamination-control-strategies-a-path-for-quality-safety (accessed Jul. 21, 2025).

Michelle Heiter is laboratory and quality control specialist at Regulatory Compliance Associates, a Nelson Labs Company.

Susan J. Schniepp, is distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company.

®
Vol. 49, No. 7
September 2025
Page: 34

When referring to this article, please cite it as Heiter, M. and Schniepp, S. Effectively Using Contamination Control Strategies.

Articles

A contamination control strategy (CCS) is essential in pharmaceutical manufacturing to ensure product safety, regulatory compliance, and operational efficiency. It aligns with EU and US regulations and ICH guidelines, focusing on minimizing contamination through good manufacturing practices. Key elements include monitoring, validation, contamination controls, and personnel management. A risk assessment is crucial for identifying and prioritizing contamination risks, fostering continuous improvement, and maintaining regulatory compliance. A robust CCS enhances product quality, patient safety, and company reputation by proactively addressing contamination risks.

Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company, discuss how to effectively use contamination control strategies in your operations.

Effectively Using Contamination Control Strategies

Ask the Expert: Studies for Extractables and Leachables

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, talks to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables (E&L). Specifically, Christiaens and Jenke highlight the differences between the E and the L in E&L and how these two compounds play off each other. Jenke goes into detail about the requirements for leachable studies, while Christiaens provides clarification on what is necessary for extractables.

“The design requirements for leachable studies are pretty clearly outlined in the global regulations,” says Jenke. “That's things like, use three batches of drug product. You use multiple time points over nominal shelf life and accelerated shelf life in order to establish trends. You use drug product units that represent commercial product. In other words, the formulation is the commercial formulation, the packaging is the commercial packaging, and the product has been manufactured using the commercial manufacturing process. There's the expectation that an eligible study has two components, targeted components, where you know it's exactly what it sounds. You know what the compounds are that you need to measure, and you validate [them]. You validate methods to do those measurements. The second component is a screening or non-target component, where you don't necessarily know what the compounds are that you're looking for, and you use qualified methods to look for these compounds above a reporting threshold. The analytical methods themselves, at least in terms of high-level, are relatively well established.”

“During a stability study, you have your different time points, and gradually you see those compounds coming out of the container closure system,” Christiaens says. “If you would not do that, then you would do some kind of impurities profiling of your drug product. That means that you would see everything that is present in the drug product without any differentiation between, is it eligible or not? And that is very important in terms of conclusions. You only want to report in this phase what is coming out of the container closure system and nothing else, because the other things will normally have been addressed in other studies. So, you don't need to repeat that over again.”

Click the video above to watch Piet and Dennis answer the following questions:

“What are the critical points in an E&L study that really need to be addressed before even considering a submission to the health authorities?”

“My company recently performed E&L studies on a product using different approaches and got different results each time. How can we be sure which results are ‘correct’?”

Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs

Piet Christiaens, PhD, is scientific director, E&L expert at Nelson Labs. Dr. Christiaens develops analytical methods and protocols for both extractables and leachables studies for the pharmaceutical and medical industries.

Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions.

Dennis Jenke, PhD, is principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions. Dr. Jenke supports the customers of Nelson Labs Europe in the discussion of general principles, concepts, tactics, and/or strategy related to chemical characterization and qualification of materials, components, and systems used in these industries.

Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, talks to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each.

Ask the Expert: Identity Testing on Final Product

 video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.

“It's an interesting question, because you're going to get the API with a certificate of analysis, and you're going to do the identity and testing on that,” Schniepp ponders. “So I understand that they're trying to get out of redundant testing, and maybe there's a different way to approach it, but at some point in the final product testing, you're going to have to come up with what is the potency of that active ingredient in your final product, which you know you're identifying it. So, I don't know if you can say, ‘my potency test counts as my identity test, and it gives me the exact amount that's in my final product’. Bit, it's usually a fairly simple test. So, I'm not sure what the benefit you gain [from not doing the test]. You're going to spend more time justifying why you're not doing an identity test than the benefit gained from, you know, just doing it.”

Click the video above to watch Sue and Siegfried answer the following question:

“My company sources our API from a third party. Do we have to conduct identity testing on the final product before distribution?”

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.

Ask the Expert: Identity Testing on a Final Product

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

Q: How can the new document from the Parenteral Drug Association (PDA), PDA/ANSI Standard 06-2025, help manufacturers and laboratories improve their culture and processes?

A: PDA/ANSI Standard 06-2025 is a consolidation of guidance documents, tools, and models to assess and improve quality culture. Companies have probably seen how the state of the quality culture can impact an organization positively or negatively. This document is a great tool to research the key aspects of culture, assess the status of your culture, and create a strategy to maintain and improve the quality culture of your organization.

Q: What is a quality culture and what does the term refer to?

A: Quality culture is something seen and felt everyday as an employee and as a consumer in our everyday lives. It is hard to put into words, but it is defined well in the PDA/ANSI 06-2025 standard as “the overriding attitude, both expressed and implied, of an organization towards quality” (1).The document breaks it down into two distinct elements: a culture of shared values, beliefs, expectations, and commitment toward quality and a structural/managerial element with defined processes that enhances quality and coordinates individual efforts. It is the cross-functional ownership of quality at all levels, as well as the beliefs and systems that drive our actions each day.

Q: What factors of a quality culture are important in the pharmaceutical industry?

A: The document has so much information on the key factors of a good quality culture.The consistent themes that stand out are:

Leadership commitment—quality accountability, recognition, feedback loop, Gemba, visionary, strategic, enablers, respect your team, humility, trust

Employee engagement and ownership—mission focused, striving for excellence

Consistent standards and expectations —all sites, all teams aligned and striving for the same outcome, courage to do what is right, communicate the behaviors that you expect

Collaboration and communication—together, sharing, learning from each other, planning

Technical excellence—which was a newer way to group concepts that companies are familiar with, such as mature systems, competence, organizational learning, technology/innovation, and agility.

Q: Can you talk about the application of these factors in a laboratory setting and how it may differ from that of a manufacturer?

A: All of the above attributes apply and are critical for a laboratory’s quality culture, but in the authors’ opinion, some items are even more critical for a testing laboratory to succeed.In a laboratory, the main resource is people, not machines or facilities. Scientific competence and a good understanding of why things are done a certain way is paramount to producing quality results and solving problems for customers. Good leadership and employee engagement can make a huge impact on quality culture and the results achieved for clients.

Q: To what extent is the customer perspective incorporated into quality decision making?

A: The customer perspective must be embedded in strategic planning, quality systems, and day-to-day activities. The customers’ product end-users, along with their regulators, determine what good quality looks like in any particular setting. If contractors are not viewing their work through their clients’ eyes, they will miss the mark on quality. Aligning employees’ responsibilities with customers’ expectations, particularly in the pharmaceutical industry, creates employee engagement as they get excited about what customers are doing. This also creates partnerships with customers that are based on achieving mutual success. What customer doesn’t want to be understood by the provider to whom they are going for a solution?

PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

When referring to this article, please cite it as Cushing, M. and Schniepp, S.J. Guidance on Quality Culture Standards. 

Guidance on Quality Culture Standards

Ask the Expert: Quality Control Units

After an FDA inspection of a pharmaceutical manufacturing facility, any deviations the inspector might find during the inspection are reported on a Form 483 and sent to the manufacturer. If the company fails to properly respond to the agency, FDA will follow up with a warning letter. A common theme seen on warning letters is that companies fail to properly establish a quality control unit. So how should a company respond if they receive such a citation?

“Well, you see the mere fact that they actually received a warning letter means that their initial response to the observations by the FDA inspectors were considered inadequate or incomplete,” Siegfried Schmitt, vice president of Technical at Parexel, explains. “I think it's therefore essential to admit that this shortcoming has happened, and so they should make sure that the response they now give to this warning letter is really a complete and convincing one and provides a remediation plan that will be acceptable to the authorities.

 video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss what manufacturers should do when they receive a warning letter from FDA for an insufficient quality control unit.

“My company received an FDA warning letter for failure to create a quality control unit. What is the best way to respond to FDA?”

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to PTProjects@mmhgroup.com, and it may appear in a future episode or print column.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.