Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Siegfried Schmitt

Q. My company got a complaint from a patient that their prefilled syringe failed to inject. We make the drug product and purchase the syringe. How do we investigate a problem with the commercial syringe component that we used?

A. The drug manufacturer is responsible in the end for whatever the product does, even if it’s made up of components where the manufacturer doesn’t really have a lot of control over.

The question is, how well have you assessed the quality of the product? Have you assessed the supplier of this syringe? Because it’s all too easy to say, “Oh, something is off the shelf.”

But just because a product has been used by many doesn’t mean it’s suitable for everyone.

If the complaint is coming from the patient and the patient is self-administering the product, did they get instructions from the physician before they got the medication? Is this human error on the part of the patient?

Even if the patient did something wrong. The manufacturer needs to take this into account and should create either patient instruction or a device that is suitable for everyone. Because you can’t just say, “Well, we only sell to those who are capable and who do it right all the time.” That would be wrong.

The device, when you look at the regulations, needs to be fit for purpose, and fit for purpose means if you have a patient population that is from young to old, from very able to handicapped, then you need to provide for all of those.

And one way to do this, to prepare for this at least, is to perform usability tests If these usability tests weren’t done with a wide enough population of potential patients, perhaps you need to go back to these tests and see if they were good enough. Did they really understand, or were these already people who were used to do such testing?

We need to be very careful with testing because we can only test a certain limited number of people. And what we have here is real-world evidence if you want, and that points to where we have a gap here.

Complaint numbers can go up and down. It’s very unpredictable. The key thing is you don’t just need to have a procedure to address complaints, but you should revisit your procedure in intervals to look at not just what the regulators are saying, but also how the business environment has changed.

Look at your communication and supply chain and check your quality agreement for its robustness and to see who is responsible for these types of complaints. Because, if you don’t spell out who is responsible in your supply agreement, there may be finger pointing. This is a shortcoming with a lot of quality agreements; they may not be granular enough.

Articles

Drug manufacturers retain ultimate accountability for performance of combination products, even when key delivery components are sourced “off the shelf.” A failed prefilled syringe complaint requires a structured investigation spanning component supplier qualification, device suitability for the intended patient population, and potential use errors during self-administration. Human factors considerations are central: instructions and device design must accommodate broad user capabilities. Complaint handling should leverage real‑world signals, periodically reassess procedures against evolving regulatory and business contexts, and ensure robust quality agreements that clearly assign responsibilities across the supply chain.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Investigating Patient Complaints About Combination Products

Ask the Expert: Enhancing Out-of-Specification Procedures

Welcome to the Ask the Expert video series. This series is an extension of PharmTech’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. Have a question you would like answered? Send it to 

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

Why do pharmaceutical companies continue to receive regulatory observations regarding out-of-specification (OOS) procedures despite clear guidance from regulators?

The issue is rarely the regulatory process itself, but rather how companies apply and interpret it, according to Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel.

A significant challenge is the creation of overly restrictive internal procedures that cause problems with the procedure, such as requiring the original analyst to complete an investigation before taking leave, which results in a delay in the investigation. To move past these bottlenecks, the experts advocate for robust trending instead of treating OOS results as isolated events. Trending helps identify recurring issues with specific methods, personnel, or aging equipment, which is often neglected in budget cycles.

Furthermore, trending should serve as a key performance indicator focused on the quality and timeliness of the investigation, rather than an unrealistic goal of having zero OOS results. Schniepp and Schmitt emphasize that investigations must extend beyond the laboratory. They recommend process mapping the entire chain of events—including sampling, which is frequently performed by manufacturing personnel without sufficient lab or quality assurance department oversight. By performing a risk assessment on the entire process, companies can predict where human error is likely to occur, allowing for faster root cause identification.

For manufacturing environments involving contract partners, it is vital that all parties operate under the same OOS procedure to ensure the integrity of the investigation. The discussion concludes that a robust OOS program requires holistic training for all staff on the entire procedure, combined with electronic systems that provide immediate access to necessary data. By focusing on process transparency and trending, manufacturers can move from reactive troubleshooting to a defensible, controlled operation.

Watch the video above to find out how Schniepp and Schmitt answer the question, “We have routinely gotten regulatory observations on our out-of-specification (OOS) procedure? What can we do to make that procedure more robust?”

Investigating Out-of- Specification (OOS) Test Results for Pharmaceutical Production. Guidance for Industry. 

https://www.fda.gov/media/158416/download

MHRA. Out of Specification Guidance. March 2, 2018. 

https://mhrainspectorate.blog.gov.uk/2018/03/02/out-of-specification-guidance/

Susan J. Schniepp is distinguished fellow at Nelson Labs and a member of 

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

Videos

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure. 

Pharma Fundamentals Episode One: Using Virtual Control Groups to Reduce Animal Testing in Drug Development

Pharma Fundamentals Episode One: Virtual Control Groups in Drug Development

, Associate Director, Product Management, Digital Projects at Charles River

Mouse. | Image Credit: ©BillionPhotos.com -stock.adobe.com

 (EMA) issued a draft qualification opinion

 for a preclinical research methodology to reduce the use of animals in specific dose-range finding studies.

 The new approach method (NAM) would replace standard animal control groups with virtual groups, and once qualified, would allow EMA to accept evidence generated from virtual control groups in medicine approval applications.

 to limit the use of animals in drug development. In April 2025, the agency published its Roadmap to Reducing Animal Testing in to modernize drug development through human-relevant science.

 The core of the initiative is the advancement of NAMs, which include advanced in vitro systems (such as organ-on-a-chip), computational modeling, and artificial intelligence (AI). 

, the FDA draft guidance to reduce or eliminate 6-month primate studies for monoclonal antibodies. The agency also qualified its first AI-based drug development tool, AIM-NASH, and updated guidance to support a transition away from horseshoe crab-derived testing, a move that could spare over one million animals annually.

 To provide regulatory certainty, the FDA launched a searchable database documenting exactly where alternative methods are currently acceptable. Furthermore, the agency has prioritized international alignment, collaborating with global regulators to ensure these new strategies are accepted worldwide.

Virtual control groups are a NAM that can be used to support initiatives to reduce the use of animals in drug development and regulation. According to EMA, characterized control data identify appropriate virtual comparator animals to create virtual control groups that are then used to conduct testing that would be traditional performed on animals.

Laura Lotfi, associate director, Product Management, Digital Projects at Charles River, says that in addition to replacing, reducing, and refining the use of animals, virtual control groups may reduce study timelines and bring more “statistical power”. However, there are limitations to their use, including the reliability of the data.

“The data are highly dependent on the quality, the completeness of the underlying infrastructure that may contain sometimes biases or gaps that can affect the reliability of those results.

They may also be less suitable for certain scenarios,” Lotfi explains. “For example, there are some studies that involve new biological mechanism or rare endpoints, maybe some species that are not very well understood, where the limited historical data are not, quietly there yet, so there is a lack of sufficient historical data that are available. In those cases, traditional approaches may still be necessary.”

In the video above, Lotfi provides an explanation of how virtual control groups are used in drug development, their limitations, and the cost associated with their implementation.

Draft qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies. EMA. March 31, 2026. Accessed April 1, 2026. 

https://www.ema.europa.eu/en/documents/other/draft-qualification-opinion-virtual-control-groups-vcg-replace-concurrent-control-groups-ccg-rat-non-glp-dose-range-finding-drf-studies_en.pdf

EMA consults on virtual control groups to help reduce animal use in medicines development. EMA. Press release. March 31, 2026. Accessed April 1, 2026. 

https://www.ema.europa.eu/en/news/ema-consults-virtual-control-groups-help-reduce-animal-use-medicines-development

FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies. 

https://www.fda.gov/media/186092/download?attachment

FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development. Press release. April 20, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-achieves-year-1-goals-reducing-animal-testing-drug-development

Laura Lotfi, Associate Director, Product Management, Digital Projects at Charles River

Laura Lotfi, associate director, Product Management, Digital Projects at Charles River. Laura is a toxicologist that specializes in digital transformation within drug discovery and safety. She focuses on integrating advanced data platforms and innovative methodologies, such as virtual control groups.

Siegfried Schmitt, PhD, Vice President, Technical, Parexel

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of PharmTech’s Editorial Advisory Board.

Draft Qualification opinion for Virtual Control Groups 5 (VCG) to replace Concurrent Control Groups (CCG) in rat 6 non-GLP Dose-Range Finding (DRF) studies. 

New Approach Methodologies (NAMs). FDA.gov. Accessed April 27, 2026. 

https://www.fda.gov/science-research/science-and-research-special-topics/new-approach-methodologies-nams

CDER/Office of New Drugs Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs). FDA.gov, Accessed April 27, 2026. 

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cderoffice-new-drugs-streamlined-nonclinical-studies-and-acceptable-new-approach-methodologies-nams

General Considerations for the Use of New Approach Methodologies in Drug Development Guidance for Industry, Draft Guidance

https://www.fda.gov/media/191589/download

Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry, Draft Guidance

https://www.fda.gov/media/189920/download

Guidance for Industry, Pyrogen and Endotoxins Testing: Questions and Answers (Edition 2)

S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals, Guidance for Industry

https://www.fda.gov/media/148475/download

Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations, Guidance for Industry

https://www.fda.gov/media/124829/download

S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling Questions and Answers, Guidance for Industry

https://www.fda.gov/media/100027/download

M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Guidance for Industry

https://www.fda.gov/media/85885/download?attachment

FDA. Reducing Animal Testing in Nonclinical Studies Year One Progress and the Path Forward, April 2026. FDA.gov. Accessed April 27, 2026. 

https://www.fda.gov/media/191986/download?attachment

FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies


Innovative Science and Technology Approaches for New Drugs (ISTAND) Program


https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/innovative-science-and-technology-approaches-new-drugs-istand-program

Virtual Consortium for Translational/Transdisciplinary Environmental Research (ViCTER)


https://www.niehs.nih.gov/research/supported/translational/victer

Lotfi L, O'Neill TW, Wilcox A, Bulera S. Virtual control groups in nonclinical research: A Re-analysis of 20 studies using virtual control group data. 

https://doi.org/10.1016/j.yrtph.2026.106077

https://www.sciencedirect.com/science/article/pii/S0273230026000504?dgcid=author

Unlock Hidden Insights: Virtual Control Groups as a Data-Driven Novel Method. Webinar. 

https://www.criver.com/resources/webinar-pi-sa-unlock-hidden-insights-virtual-control-groups-data-driven-novel-method

 Z. What Lilly’s $2.75B bet on AI-discovered drug candidates means for drug development. 

https://www.pharmtech.com/view/what-lilly-s-2-75b-bet-on-ai-discovered-drug-candidates-means-for-drug-development

Thomas F. DCAT Week 2025: Quality and compliance for animal-derived products. 

https://www.pharmtech.com/view/dcat-week-2025-quality-and-compliance-for-animal-derived-products

Haigney S. USP permits use of non-animal-derived reagents for endotoxin testing. 

https://www.pharmtech.com/view/usp-permits-use-of-non-animal-derived-reagents-for-endotoxin-testing

Thomas F, Haigney S. Non-animal-derived reagents for endotoxin testing. 

https://www.pharmtech.com/view/non-animal-derived-reagents-for-endotoxin-testing

Haigney S. The impact of USP Chapter <86> on endotoxin testing. 

https://www.pharmtech.com/view/the-impact-of-usp-chapter-86-on-endotoxin-testing

Focusing on the Fundamentals of Formulation


https://www.pharmtech.com/view/focusing-on-the-fundamentals-of-formulation

https://www.pharmtech.com/view/ich-q6b-for-analytics

Design Quality in Pharmaceutical Design: A Primer for Facility Executives


https://www.pharmtech.com/view/design-quality-in-pharmaceutical-design-a-primer-for-facility-executives

 Pharma Fundamentals video series. Episodes in this educational series aim to provide knowledge in the basics needed for pharmaceutical development and manufacturing, such as chemistry and pharmacology, breaking things down to the basics to help those working in the industry to better perform their jobs. Be sure to check the episode webpage for more topic information and resources. We hope you enjoy the series.

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

Pharma Fundamentals: Using Virtual Control Groups to Reduce Animal Testing in Drug Development

Ask the Expert: Investigating Patient Complaints About Combination Products

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. Have a question you would like answered? Send it to 

In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, address the complexities of investigating patient complaints regarding pre-filled syringe (PFS) and combination products. Schniepp and Schmitt make it clear; for manufacturers who purchase commercial syringes for their drug products, the marketing authorization holder (MAH) remains ultimately responsible for product performance, regardless of their level of control over the component manufacturer.

Investigating these types of events comes with complications, such as the lack of physical evidence (eg, returned devices, photos, or videos) when products are self-administered at home. While the rise of home-administered medications like GLP-1s has tempted some firms to cite “human error” as a root cause, manufacturers must ensure devices are “fit for purpose” across diverse populations, including the elderly and those with disabilities. If real-world evidence reveals a performance gap, it may indicate that initial usability testing may not have been sufficiently varied or robust.

There are also limitations with traditional corrective and preventive actions and recall procedures for these types of complaints. Identifying specific patients for recalls is often impossible once a product is dispensed, and privacy laws, such as HIPAA in the United States, can hinder a manufacturer’s ability to gather critical patient-specific investigation data. Furthermore, responding to patient complaints requires different language than communicating with healthcare professionals to ensure the investigation's logic is understood.

To manage these risks, the experts stress the importance of highly granular quality agreements. These agreements must move beyond simple checklists to explicitly define which party takes the lead in investigations, preventing a “blame culture” between drug manufacturers and component suppliers. Finally, companies must regularly revisit complaint procedures to adapt to evolving business environments, such as direct-to-patient shipping, to ensure they can effectively defend their “effectiveness checks” during regulatory inspections.

Watch the video to find out how Sue and Siegfried answer the question, “My company got a complaint from a patient that their prefilled syringe failed to inject. We make the drug product and purchase the syringe. How do we investigate a problem with the commercial syringe component that we used?”

Ask the Expert: Proactive Measures to Address Drug Recalls

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. Have a question you would like answered? Send it to 

In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discussed the recurring problem of product recalls and the proactive measures companies can take to prevent them. Schniepp and Schmitt identify microbial contamination, mislabeling, and physical contaminants like glass particulates as primary drivers of high-level recalls. Despite established quality systems, failures still occur due to systemic vulnerabilities such as reliance on subcontractors, production time constraints, and human error.

Discovery of these issues often occurs "in the field" when patients or doctors report adverse effects to the Adverse Drug Reporting Center. While the FDA usually does not mandate a recall, a company should respond to a high volume of complaints by initiating a voluntary recall to prevent patient harm. Microbial contamination is highlighted as a particularly challenging area because sterility assurance is a matter of probability rather than absolute testing. To combat this, companies should implement a comprehensive contamination control strategy that synthesizes data from environmental monitoring, gown swabs, and water systems.

Schniepp and Schmitt also address the serious risk of product mislabeling, which can lead to patients receiving the wrong dosage or drug. Such errors frequently occur before labeling even begins, such as vials are transported on carts with handwritten, temporary labels that are prone to human error. Because these vials look identical before labeling, a simple human mistake in marking a cart can lead to the wrong product being labeled correctly. To mitigate these risks, the quality unit should not remain isolated but should instead walk the shop floor to identify vulnerabilities that operations teams might overlook due to routine.

Prevention requires more than just possessing standard operating procedures. Companies must regularly test their recall procedures to ensure they can track and retrieve products across complex, global supply chains. Ultimately, the best defense against a recall is a "finely balanced" and well-understood quality system that incorporates International Council for Harmonisation Q10 risk management principles and maintains integrated controls across all manufacturing stages to provide total oversight.

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of PharmTech’s Editorial Advisory Board.

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of PharmTech’s Editorial Advisory Board.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

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 biopharmaceutical requirements.

It's, the next episode of Ask the Expert.

I'm Sue Schniepp, and I'm with Nelson Labs', Regulatory Compliance Associates. And I'm joined by my colleague, Siegfried Schmitt, as always, with Parexel.

And Siegfried, you have a question from an audience member or a follower of ours. So, let's go to it.

And indeed, the question that came in here is, "I see on the FDA website that a variety of recalls occur, and these occur quite often. What can we, in our company, do to prevent having a product recall?"

Well, you know, that's interesting. It depends on, you know, what the product's being recalled for, and there's levels of recall, right? There's high, you know, level one, level two, level three.

So, let's talk about the serious ones. And a lot of those, from what I see, are, some microbial contamination, mislabeling, and, you know, how there were some glass particulates, in a couple of the products that I looked at. So that is the role of the company then is to find out what's causing those.

How you prevent them, that's another story.

It's, you know, how did they get there drives how you prevent recalls? What are the reasons for these recalls?

What we don't see from there is, of course, what the root causes, for these issues are.

Now, we see, as you said, Sue, there are some that are particulates in there, sterility, and mislabeling.

Now, all these activities are, of course, covered by the quality system.

There are activities, actions, controls in place, be it through testing, be it through, second

And so still, despite all these activities, we find we have recalls necessary because something's mislabeled.

And we then therefore have to ask ourselves, how can these issues happen despite all these safeguards?

And of course, from our experience in industry, we can say there are many, opportunities that things can go wrong, not least when you do not do things in-house, when you have a lot of subcontractors helping you because you rely on something that is not under your complete control.

Or if you do things in-house, it could be also time constraints. You go rushed through the production, through the release, whatever.

But perhaps we should also look at who actually identifies these issues, who recognize these issues.

So perhaps, Sue, you could say a few words about that.

Who are the ones who make the discovery? Well, that's interesting.

Oftentimes it comes from the field, and you'll get, reports from adverse effects, of patients who have been given the medication, or, in the case of like eye drops, somebody, using eye drops, there were a few, listings of microbial contamination in eye drops.

They'll go to their doctor and complain about their vision and not getting better because the eye drop is contaminated.

So that goes through the Adverse Drug Reporting Center, and usually there's a a tipping point.

You get so many complaints, and those are given to the company who's manufactured the product.

Then they get so many complaints. It, it's interesting in the US, the FDA cannot tell you to recall something. It's voluntary, but they can strongly recommend it.

But when you get so many complaints, then you're obligated to recall because obviously there's something wrong with your product.

Now if we focus a little bit on the microbial because that's the one that is the hardest to pinpoint, right?

And there could be a number of reasons, why, why you're going to get microbial contamination.

And it spans, you know, from medicated hair shampoo, to eye drops, to nasal sprays to injectables.

You can get that microbial contamination.

There's a lot of avenues to go down, and each are important.

So, let's kind of pick apart that yes, you're right. And we have to, of course, also see that sterility assurance is a probability.

You cannot test a hundred percent. You have a probability that things are sterile, And, therefore, there is a higher risk there that you may have contaminated product somewhere. It may not be how you sterilize. It may also, as you say, how you clean, how you sample.

Is your sample even representative of what you're doing in the plant?

So, there are various, root causes that we can think of, and it may take some time to find these root causes.

And something you already mentioned is there are different, seriousness, levels about these, product issues.

Of course, if it's the wrong product label, we don't even know what the product is because it's the wrong label. If it's non-sterile, we may not be able to see it, but we may, suddenly have side effects from it, and so on.

So, it's not always obvious to the patient or to the medical practitioner what exactly is happening here or not. So, sometimes it may be sufficient to provide extra information if it's not a very serious issue.

So, you simply tell the patients who are using your product, maybe they need to avoid using it with a particular liquid, such as milk or so, or maybe they just need to be clear, it is not for, let's say, pregnant women or something like that.

But if it is more serious, then yes, the recall itself means you have to bring it back from the market, and you have to bring it back from the market whether you know the root cause or not, because it causes harm to patients.

That, that means, you will have to try and find each and every piece of product that is out there that has to come back.

And that is something that is not trivial because as we know, supply chains these days are often global.

So, how you recall a product that is on a lorry somewhere in Tajikistan or whoever knows where else, is not trivial.

So, that means you need to be prepared for these things. So, it's not just suddenly being in the situation, oh, we need to do a recall.

Oh, yes, we have an SOP. But have you tested it?

So I think so. You can say things to are you being prepared or not?

It's kind of like car insurance. You have it, but you don't really want to use

It. So yeah, but you do have to test, not your car insurance, you do have to test your recall procedure to make sure that you can account for all the vials out there.

You struck a chord with me when you said the mislabeling because that too is a very serious, recall, and the potential there is for the patient to get the wrong dosage or the wrong drug completely.

And that's, another one, it's hard, you know.

There's a lot of electronic systems, and I think people are starting to employ AI in their label reading, capabilities, right?

Not that the, the human would make mistakes, but how do we prevent that from happening?

I was actually surprised that there were labeling, issue recalls, and it was for dosage strengths.

Well, I have to say I'm not so surprised about this because it is not, in my experience, the activity of fixing the label. It is before that.

What you have is you have the naked vials, the naked ampoules, whatever it is, and they come to the area where all the labeling and packaging occurs.

And you can't distinguish one vial from another.

They all look the same, and they are on carts, and the carts should be properly labeled.

And what happens is these carts aren't labeled permanently because they're reused for

different products, and someone writes in handwriting on there what it is on this cart.

You make an error as a human being, and there you go.

You got the right label but the wrong product.

And because at this point you have already taken your samples and tested and whatever, and you no longer repeat these tests.

So, there is a possibility that it slips through, and suddenly you got the wrong label on the correct vial or the other way around.

Failure of your quality system to catch these kinds of errors. Somewhere you have a vulnerability, kind of like with, you know, data integrity. You look for those areas where you can drive that behavior of poor data, governance.

So, is it the same on the manufacturing line?

Seems to me you have to look for those areas where, at least in the case of the labeling,

In this episode of Ask the Expert, Susan J. Schniepp and Siegfried Schmitt discuss how companies should approach preventing product recalls.

Q: We are updating our training program for this year and wondered, are you aware of any new regulations for data integrity?

A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, address data integrity within the context of revised or new parts of the legislation.

 the Revision of Good Manufacturing Practice (GMP) Guidelines Chapter 4 (Documentation), Annex 11 (Computerised Systems) and New Annex 22 (Artificial Intelligence) for public consultation. All 3 documents address data integrity, namely:

Chapter 4 clarifies the requirements for the management of electronic records, signatures, and data integrity while ensuring consistency with the concurrent revision of Annex 11.

Annex 11 strengthens controls related to the assurance of data integrity, audit trails, electronic signatures, and system security.

Annex 22 addresses the quality of model training data, and the management and processing of test data for AI models.

No new stand-alone 2025 data integrity regulations were issued, but regulators are embedding data integrity expectations into broader GMP and quality initiatives. The European Commission’s proposed updates to GMP Chapter 4, Annex 11, and a new Annex 22 explicitly address electronic records, computerized system controls, audit trails, electronic signatures, security, and AI model data governance. FDA’s CDER 2026 Quality Management Maturity prototype similarly elevates data governance beyond baseline cGMP. Core expectations remain anchored in ALCOA+ and persistent inspection findings often trace to weak documentation discipline.

It is necessary to search beyond the term “data integrity” to stay abreast of developments in this field, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.