How digital container twins can improve pharma manufacturing

Manufacturing Intelligence: Digital Twins Meet Pharma Containers

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

How evolving regulatory expectations are reshaping pharma development and manufacturing.

Drug Digest April 2026

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

PharmTech Weekly Roundup-May 15, 2026

The pharmaceutical landscape is currently defined by three intersecting trends: rapid technological integration on the factory floor, a strategic shift toward globalized development networks, and significant leadership upheaval at the regulatory level. As manufacturing lines adopt advanced automation and AI to meet stricter sterility standards, the industry is simultaneously navigating a period of unprecedented volatility within the FDA. Furthermore, the ongoing challenge of supply chain resilience is forcing a move away from reactive inventory management toward data-driven, clinical-centric strategies.

 resigned following industry pressure, leaving the agency in a state of regulatory flux, underscoring a period of significant turnover and potentially impacting the stability of drug review initiatives. The resignation followed earlier reports that said the 

White House was planning to remove the commissioner.

entered into an agreement this week that highlights the strategic use of China's accelerated development timelines to generate early clinical data and de-risk global drug portfolios.

Manufacturing trends discussed this week include the use of 

, which are increasingly utilizing isolator technology, automation, and AI-driven analytics to enhance sterility assurance and meet stringent global regulatory standards like EU GMP Annex 1.

 by prioritizing proactive communication with health systems and implementing end-to-end inventory visibility tools compatible with hospital automation.

, implementing validated electronic master production records with structured governance is essential for strengthening data integrity and ensuring GMP inspection readiness throughout the manufacturing lifecycle.

focused on clinical criticality and cross-hospital collaboration is necessary to move past reactive hoarding and ensure medications reach the patients who need them most.

These shifts in technology, policy, and supply chain strategy require manufacturers to remain agile and data-focused. For in-depth analysis on any of these topics, please refer to the full reports on PharmTech.com.

Videos

This week, the industry saw rapid technological integration on the factory floor, a strategic shift toward globalized development networks, and leadership upheaval at the FDA. 

President 
     Concordia MCS, LLC
Scientific Advisor 
     SmartSkin Technologies

Senior Director
Education, Outreach, and Digital Experience
Open Biopharma Research and Training Institute

, co-hosts Chris Cole and Richard Jaenisch explore the emerging role of digital twins in pharmaceutical container systems with guests Mihaela Simianu, president of Concordia MCS and scientific advisor to SmartSkin Technologies, and Austin Caudle, vice president at SmartSkin Technologies.

To view the full fascinating, practical, engaging conversation, click here!

The discussion centers on how “smart” pharmaceutical container replicas—equipped with sensors and data-capture capabilities—can help manufacturers better understand how vials, syringes, cartridges, and other container closure systems interact with manufacturing equipment throughout the product lifecycle. Simianu explains that while today’s technology is not yet a fully virtualized digital twin, these physical smart replicas provide critical real-time data about seal forces, equipment interactions, and operational stresses that can impact product quality and patient safety.

The guests emphasize that container intelligence can play a significant role across development, clinical manufacturing, commercial scale-up, and tech transfer between manufacturing sites and CDMOs. By using sensor-enabled replicas to monitor equipment-container interactions, companies can reduce glass breakage, minimize downtime, optimize line setup, and better maintain container closure integrity throughout production and distribution.

A key theme throughout the conversation is risk reduction. Simianu and Caudle argue that integrating these tools early in development creates continuity as products move between facilities and scales, helping manufacturers preserve process understanding and reduce variability tied to changing equipment environments.

The episode also highlights broader industry trends toward data-driven manufacturing, predictive analytics, and digital transformation, positioning smart container technologies as foundational building blocks for the future of pharmaceutical digital twins and advanced manufacturing intelligence.

Mihaela Simianu and Austin Caudle join the show to discuss how digital container twins can improve pharma manufacturing, validation, and risk reduction.

George Kwiecinski, Global Key Solutions Corp

connected with George Kwiecinski, CEO and co-founder of Global Key Solutions Corp, to discuss FDA GMP inspection trends, supplier oversight gaps, and the rising regulatory scrutiny of AI in pharma compliance.

Watch the full video interview with George Kwiecinski:


George Kwiecinski on Why Now Is the Time to Reassess Your GMP Audit Strategy

PT: How Should Quality and Compliance Teams Prioritize Foreign Suppliers for Audit or Reinspection when Inspection Coverage Is Limited?

Kwiecinski: It comes down to resources and organizational capacity. Whether you're inspecting an internal facility or auditing a supplier, most organizations are working within real constraints. The question becomes: are you procuring the right tools and technology to make sound assessments? Are you selecting suppliers through a documented, demonstrable process? These aren't just best practices, they're expectations. With the QMSR changes affecting both medical devices and the FDA's ability to scrutinize internal audit documentation, this has become a hot-button issue. Organizations need to take a second look at how those processes are being handled and reprioritize accordingly. The good news is that tech stacks have improved significantly for most workflows, so there's really no excuse not to reassess.

What's Your Outlook on Compliance Risk in Global Supply Chains?

Honestly, I don't think the fundamental risk picture changes dramatically. The top citation areas will continue to revolve around the quality unit, drug efficacy and safety standards, and how those standards are being enforced across vendors. Those core pillars aren't going anywhere. What will shift is the context around them, especially as new technologies and practices become more common in the industry.

How can AI-powered Regulatory Intelligence Improve Oversight without Providing False Positives or Incomplete Data?

Yes, this is something we've been tracking closely. One trend that really made waves recently was that an AI citation appearing in an FDA warning letter. Essentially, a company had used AI to respond to the FDA and generate some of their documentation, and that usage was called out directly. Now, I think this kind of citation will become more frequent over time. It may not always be flagged explicitly, but AI use in regulatory processes is clearly on the FDA's radar.

We put together a white paper recently looking at how the FDA has used ‘AI’ as a keyword across its correspondence and documentation over the last 3-4 years. What we found was telling: there are now 5 distinct regulatory correspondences specifically referencing AI, and over 20 FDA guidance and documents that mention it, with the frequency increasing steadily over time. That trajectory tells us that AI is becoming a meaningful part of the agency's regulatory purview, and companies need to start thinking about what that means for them.

What Changes Do You Recommend to Strengthen Foreign Supplier Governance when API and Finished-dose Sourcing Is Heavily Concentrated Overseas?

The first step is just awareness, understanding that these changes are happening and that it's accelerating. From there, it's about looking at your own tech stack and honestly evaluating how your organization is managing AI-related risk. If your organization is using AI tools in any part of its regulatory or quality workflow, you need to be thoughtful about how those decisions are documented and defended.

As for whether companies should invest in new AI tools, I think that's a legitimate conversation to have, but the justification has to be grounded in business reality. If a tool can demonstrably save cost or drive profit, and you can implement it in a safe, controlled way, then pursuing it makes sense. What's going to matter most though, is the risk-based approach: how are you accounting for AI-assisted or AI-driven decisions within your processes? That's exactly the kind of thing that's subject to FDA scrutiny right now.

Articles

Global supplier oversight remains constrained by finite audit resources, elevating the importance of documented, defensible risk prioritization and fit-for-purpose technology. Persistent GMP citation drivers—quality unit effectiveness and enforcement of efficacy/safety standards across vendors—are expected to continue, but will be reframed by expanding use of AI in quality and regulatory workflows. FDA attention to AI is increasing, including explicit mention in warning-letter context and growing references across agency correspondences and guidances. Organizations should reassess audit strategies, strengthen governance of overseas sourcing, and formalize controls for AI-assisted decisions.

George Kwiecinski, Global Key Solutions Corp, breaks down GMP inspection risks, global supply chain compliance, and AI's growing role in FDA regulatory scrutiny.

Q&A: George Kwiecinski on How AI Is Reshaping FDA Regulatory Compliance

Valerie Bandy brings over 25 years of distinguished experience in healthcare leadership to her current role as Vice President Pharmacy Solutions at Tecsys. With a career marked by this steadfast leadership, she has consistently excelled in driving strategic initiatives and optimizing operational efficiency. In her present capacity, Valerie collaborates closely with sales, research and development, AI and marketing teams to refine pharmacy supply chain software solutions, leveraging her extensive expertise in healthcare operations, sales strategy, supply chain, consulting, and regulatory compliance. Prior to her tenure at Tecsys, Valerie held pivotal leadership roles at prominent healthcare institutions including Director of Pharmacy at Wellstar Atlanta Medical Center, System Director of Pharmacy operations at Trinity Health, and consulting firms including Deloitte Consulting where she was a Specialist Master, and PriceWaterhouse Coopers. Throughout her career, she has spearheaded initiatives that have significantly impacted pharmaceutical procurement, cost optimization, and operational excellence, managing multi-billion-dollar budgets with adept precision. Valerie's academic credentials include a Doctor of Pharmacy, an MBA, and a Bachelor of Science in Biology, underscoring her commitment to academic excellence and professional development. Driven by her passion for healthcare leadership, Valerie actively seeks opportunities that align with organizational missions and visions, embodying a steadfast dedication to advancing healthcare delivery and patient outcomes.


Valerie Bandy, Tecsys, discusses how pharmaceutical manufacturers and health systems can work together to build more strategic, resilient drug supply chains.

Watch the 2-part video interview with Bandy:
Part 1: 

Valerie Bandy on Building Smarter Pharma Supply Chains

Valerie Bandy on Reducing Drug Shortages Through Smarter Inventory Management

PT: How Should Manufacturers Think About Health System Roles in Supply Chain Strategy?

: Manufacturers must look at things from the health system's perspective. They're constantly balancing supply chain resilience against operational realities. Every new vendor relationship requires qualification, contract negotiation, and regulatory alignment specific to each drug and patient population.

The real lesson is that manufacturers are not invincible. Disruptions do happen, and how they support health systems through those moments matters enormously. Their goal should be building strong standing relationships with health system leaders and structuring contracts that genuinely reflect how those systems function.

What Should a Mid-Size Pharmaceutical Manufacturer Understand About Obligations to Health Systems?

The size of the company is largely irrelevant; what matters is the drug. Regardless of the size of the organization, if their product is meeting a need for a specific patient population or disease state, the expectations placed on them are the same. Clear, proactive communication with health system contacts is critical, particularly around any supply disruptions or technologies that can help health systems gain better visibility into their inventory.

At Tecsys, our pharmacy solution is designed to provide end-to-end visibility into where any drug is sitting at any given time, whether on a shelf or in automation. Manufacturers should be asking themselves whether their product is compatible with automated dispensing machines, where their disruption risks lie, and how they can mitigate those risks internally before they become a problem for the health system.

What Is the Biggest Operational Challenge on the Health System Side During a Shortage?

There is a significant reliance on manual workarounds. When a drug becomes unavailable, pharmacy teams may need to compound it themselves, and there is often delayed escalation, people can become somewhat desensitized to shortage alerts and default to reactive decision-making rather than executing a prepared plan.

Health systems need a tiered strategy: a prioritized list of critical drugs whose absence would seriously compromise patient care, paired with clearly defined contingency plans for each. The goal is to move away from hoarding behavior, ordering as much as possible the moment a shortage signal appears, toward a more calibrated response based on actual patient volume, existing inventory across all locations, and true clinical need.

How Should Manufacturers Think About Drug Allocation During a Shortage?

Allocation decisions should go well beyond raw data. A health system that rarely treats a particular disease state may not require a large allocation, even if their procurement team is anxious about coverage. Meanwhile, a system that manages dozens of those patients daily absolutely needs to be prioritized. Manufacturers need to understand what each health system is known for, what their patient population looks like, and what the absence of that drug would truly mean for care delivery.

Pharmaceutical manufacturers should design supply strategies around health system operational constraints, recognizing that qualification, contracting, and regulatory alignment make vendor changes burdensome. Manufacturer resilience is not guaranteed; proactive relationship-building and contracts reflecting real workflows are pivotal during disruptions. Company size matters less than drug criticality, making transparent, early communication on shortages essential. Health systems often default to manual workarounds and reactive behavior, underscoring the need for tiered critical-drug prioritization and contingency planning. Allocation should incorporate clinical demand and service-line realities, not procurement anxiety.

Valerie Bandy, Tecsys, explains how proactive vendor relationships, strategic drug allocation, and end-to-end visibility can prevent costly pharmaceutical supply disruptions.

Q&A: How Manufacturers Can Prevent Drug Shortage Crises

Emily Schirmer, Catalent, explains how to accelerate the path to first-in-human trials as biologics pipelines grow more complex and timelines tighten.

How Biologic Developers Use Optimized Platforms and Operations to Reach First-in-Human Trials

As biologics pipelines expand, developers face increasing pressure to reach first-in-human (FIH) milestones quickly while managing growing molecular complexity, tight timelines, and evolving regulatory expectations. In this discussion, Emily Schirmer, general manager at Catalent Pharma Solutions’ Madison, Wisconsin site, shares insights on how early strategic decisions in chemistry, manufacturing, and controls (CMC) can influence clinical success.

Schirmer emphasizes that process development and manufacturing considerations are often introduced too late, placing them on the critical path. Engaging early with a CDMO partner with appropriate scale, capacity, and scientific expertise can help streamline development, minimize tech transfers, and support continuity from early-phase through commercial manufacturing. She also highlights the importance of evaluating the full supply chain upfront—drug substance, drug product, fill-finish, packaging, and distribution—and how those capabilities are coordinated across a CDMO's network of sites.

Speed to clinic remains a central priority, particularly for emerging biopharma companies, where rapid progression to proof-of-concept can impact funding and competitive positioning. However, this urgency must be balanced with reliability. Schirmer underscores the value of strong, transparent partnerships between sponsors and CDMOs, built on shared goals, accountability, and collaborative problem-solving.

As molecules progress through development, change is inevitable. Whether driven by process optimization, evolving quality requirements, or adoption of new technologies, these changes must be carefully managed using data-driven and risk-based approaches to support regulatory alignment and reduce the risk of timeline impact.

Schirmer also highlights the advantages of Catalent's Madison, Wisconsin site, where drug substance process development, engineering, GMP manufacturing, and quality teams are co-located—enabling faster decision-making and closer sponsor collaboration for the drug substance portion of the program.

Finally, she points to innovation in cell line development as an important enabler of both speed and efficiency. Advances in expression systems and the integration of technologies such as gene editing are supporting increasingly complex biologics while helping to reduce cost of goods and improve timelines.

Senior Content Associate For Pharmaceutical Commerce

New York, USA - 15 February 2021: FDA US Food and Drug website in browser with company logo, Illustrative Editorial. | © Postmodern studio - stock.adobe.com (414656141)

Marty Makary, Commissioner of the FDA, is stepping down following a turbulent tenure defined by senior leadership attrition, inconsistent regulatory decision-making, and sustained pushback from pharmaceutical stakeholders.

 His exit comes after escalating criticism from drug manufacturers, anti-abortion groups, and vaping industry lobbyists.

Kyle Diamantas, the agency's current Chief of Foods and a Trump-aligned attorney, will assume the role of acting commissioner as the White House initiates a search for a permanent, Senate-confirmed successor.

Makary, a surgical oncologist and health researcher, rose to political prominence as a critic of pandemic-era health mandates.

 However, his transition to regulatory leadership was fraught with administrative challenges. Under his leadership, the FDA experienced significant turnover, as many senior career officials resigned, retired, or were forced out within the first year of the administration.

This revolving door of leadership, combined with allegations that scientific principles were frequently overridden by political interests, specifically those of Health and Human Services Secretary Robert F. Kennedy Jr., reportedly lowered staff morale and created a climate of dysfunction and frustration.

How Will Makary’s Resignation Impact the Pharmaceutical Sector?

Makary’s impending departure highlights a period of regulatory unpredictability. While Makary promoted initiatives to streamline drug reviews, including the integration of artificial intelligence and dropping certain study requirements, these efforts were sometimes eclipsed by regulatory unpredictibilty.

Industry executives noted that the agency sometimes issued rejection letters for therapies that had previously received preliminary support from FDA staff. A high-profile example involved Replimune’s melanoma therapy, which was rejected twice, leading the company to accuse the agency of contradicting its own earlier positions.

 Such inconsistencies have created significant hurdles for drugmakers, investors, and patients who rely on the predictability of the regulatory process.

Furthermore, the agency faced backlash for its handling of vaccine eligibility. According to the AP, Dr. Vinay Prasad, Makary’s deputy, was reported to have at times overruled or clashed with career staff in decisions involving access to new COVID-19 shots and initially declined to consider a new mRNA flu vaccine from Moderna.

 That decision was reversed after Moderna indicated it would challenge the decision and request intervention from the White House, further signaling a breakdown in standard regulatory order.

In recent weeks, Anti-abortion groups criticized the commissioner for allegedly delaying a review of the abortion pill mifepristone.

 Simultaneously, vaping lobbyists successfully pressured the administration after claiming Makary was blocking the approval of fruit-flavored e-cigarettes. The FDA 

authorized the first of such products last week

With Makary’s exit, the fate of several fledgling programs remains uncertain. Many of his initiatives to speed up drug reviews have not undergone the formal federal rule-making required to be enshrined in U.S. regulations, leaving them vulnerable to being overturned by his successor.

 The transition to acting leadership under Diamantas may offer a pause in the recent cycle of controversial mandates, but the search for a permanent, Senate-confirmed commissioner suggests that a period of regulatory flux could continue.

Abutaleb, Y. Makary resigns as FDA commissioner after turmoil. 

. Published May 12, 2026. Accessed May 12, 2026. 

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-commissioner-makary-is-resigning-politico-reports-2026-05-12/

Perrone, M, and Min Kim, S. Makary resigns as FDA commissioner amid agency turmoil, sources say. 

https://apnews.com/article/fda-trump-makary-kennedy-vaccines-drugs-ef151784342c48cca3b91a829d615b5e

Marty Makary is stepping down as FDA commissioner amid persistent leadership turnover, declining staff morale, and perceptions that scientific review was subordinated to political priorities. Acting leadership will shift to Kyle Diamantas while a permanent successor is sought. Drug developers faced heightened regulatory unpredictability despite efforts to accelerate reviews via AI and reduced study requirements, with notable reversals and surprise rejections. Controversies around vaccine eligibility decisions, mifepristone review timing, and fruit-flavored e-cigarette authorizations intensified external pressure and underscored ongoing institutional instability.

FDA Commissioner Marty Makary resigns amid agency turmoil, staff exodus, pressure over vaccines, rulings on abortion pills, and vaping rules.

FDA Commissioner Marty Makary Resigns Following Industry Pressure

Christian Houborg discusses how FUJIFILM Biotechnologies is helping customers navigate evolving patient demand and supply chain uncertainty.

FUJIFILM Biotechnologies Denmark: Addressing Evolving Patient Demand with Speed and Flexibility

Christian Houborg, general manager and senior vice president of the Denmark site at FUJIFILM Biotechnologies, highlights the rapid growth and expanding capabilities of the company’s Denmark site, positioning it as one of the largest biomanufacturing facilities of its kind in Europe. Over the past several years, the site has doubled in size, expanded its reactor capacity, and added fill-finish capabilities, enabling comprehensive end-to-end services that include drug substance manufacturing, drug product, assembly, labeling, packaging, and quality control support.

Houborg emphasizes the site’s extensive expertise in large-scale biologics manufacturing and its strong track record in technology transfers and product introductions. He notes that the Denmark team successfully completed 10 process performance qualification (PPQ) campaigns within the last 18 months and maintains a history of 30 successful validated production campaigns overall. According to Houborg, this success stems not only from technical expertise and engineering strength, but also from a collaborative culture focused on speed, flexibility, and close partnerships with customers.

He also describes the strategic advantages of FUJIFILM Biotechnologies’ global manufacturing network, particularly the mirrored capabilities between the Denmark site and the company’s expanding facility in Holly Springs, North Carolina. The “identical twin” approach creates standardized manufacturing environments across regions, allowing customers to seamlessly transfer production between facilities while minimizing risk and accelerating scalability. Combined, the Denmark and Holly Springs campuses ultimately support nine large-scale drug substance factories designed around the same operational setup, offering manufacturing flexibility and supply chain resilience.

Houborg underscores the company’s commitment to sustainability and operational efficiency. The Denmark site holds EcoVadis Gold certification and continues to focus on reducing energy and water consumption while advancing broader sustainability initiatives.

Looking ahead, Houborg positions FUJIFILM Biotechnologies’ global network as a strategic solution for navigating geopolitical uncertainty and evolving supply chain demands. By maintaining aligned infrastructure and operational standards across Europe and the United States, the organization aims to provide customers with manufacturing agility, dual sourcing opportunities, and long-term supply security regardless of global market changes.

China’s Rising Role in Drug Development 

A new global licensing and research agreement between Bristol Myers Squibb (BMS) and Hengrui Pharma highlights the trend of US pharma companies using China-based firms’ early clinical development infrastructure to accelerate proof-of-concept decisions.

 The agreement includes $600 million upfront and could reach $15.2 billion in total value, spanning 13 early-stage programs across oncology, hematology, and immunology.

“Tapping capabilities across geographies could cut the time to early clinical insights and support informed decisions,” Robert Plenge, MD, PhD, research chief, Bristol Myers Squibb, stated in a press release,

  Plenge points less to a single asset transaction than to a broader portfolio strategy built around trial-start speed, earlier human data generation, and regional division of development responsibilities.

The transaction gives BMS exclusive rights to four Hengrui oncology and hematology assets outside the mainland of China and establishes joint discovery and development work on five additional candidates.

 The structure also includes rights granted to Hengrui for four BMS immunology assets in China, with Hengrui taking responsibility for early development in humans.

Rather than relying only on external in-licensing, the arrangement also places internal BMS candidates into a regional development model designed to reach clinical proof of concept more quickly.

These structures can affect clinical supply planning, analytical transfer, comparability strategy, and regulatory sequencing across regions.

Why is China-based Development Becoming so Prevalent?

This deal is a part of a broader industry movement toward China for early clinical work. The interval from early discovery to clinical trial filing is 50% to 70% faster in China than in the rest of the world.

That speed differential has implications for portfolio governance because earlier first-in-human data can shape whether sponsors expand process development, scale-up activities, and later-stage manufacturing investments.

Working with a China-based firm may offer accelerated enrollment and startup timelines but also earlier feedback on formulation suitability, biomarker strategy, and dose-selection assumptions.

 Those advantages, however, do not remove the need for careful global development planning, particularly where data packages will later support multinational regulatory interactions.

How Does this Deal Compare With Other Hengrui Partnerships?

The BMS-Hengrui alliance is different from previous deals Hengrui made with US-based firms because it includes assets from both parties rather than a simpler one-way license.

 A bidirectional arrangement may create a more integrated development network, potentially involving shared decisions about candidate selection, early clinical execution, and future commercialization options.

GSK entered a separate Hengrui transaction in 2025 involving one licensed candidate and options on 11 other programs, with Hengrui positioned to advance those assets through phase 1.

 GSK paid $500 million upfront for the collaboration and did not include exclusive rights to any products in their drug portfolio for Hengrui. These agreements suggest sustained interest among large drug developers in accessing China-originated assets and development capabilities.

What Are the Operational limits of this Deal?

No asset-level efficacy, safety, or clinical trial design data were disclosed, limiting assessment of scientific risk, manufacturability, and modality-specific development complexity.

 The practical value of the agreement will depend on whether faster, early studies translate into decision-quality data that can support later global development.

At the moment, the transaction is best understood as large pharma companies pairing external pipeline access with regional early-development execution in an effort to shorten the path to proof of concept.

Bristol Myers Squibb. Bristol Myers Squibb and Hengrui Pharma announce strategic agreements to advance innovative medicines across oncology, hematology, and immunology. Press release. May 12, 2026. 

https://news.bms.com/news/details/2026/Bristol-Myers-Squibb-and-Hengrui-Pharma-Announce-Strategic-Agreements-to-Advance-Innovative-Medicines-Across-Oncology-Hematology-and-Immunology-2026-EbQpaI6Zdc/default.aspx

McKinsey & Company. The emerging epicenter: Asia’s role in biopharma’s future. Accessed May 12, 2026. 

https://www.mckinsey.com/industries/life-sciences/our-insights/the-emerging-epicenter-asias-role-in-biopharmas-future

Hengrui Pharma Co. Ltd.; GlaxoSmithKline plc. Hengrui Pharma and GSK enter agreements to develop up to 12 innovative medicines across respiratory, immunology & inflammation and oncology. Press release. July 27, 2025.

https://www.prnewswire.com/news-releases/hengrui-pharma-and-gsk-enter-agreements-to-develop-up-to-12-innovative-medicines-across-respiratory-immunology--inflammation-and-oncology-302514566.html

Bristol Myers Squibb and Hengrui Pharma formed a global licensing and research collaboration leveraging China-based early clinical development to accelerate proof-of-concept decisions. The deal includes $600 million upfront and up to $15.2 billion total value across 13 early-stage programs in oncology, hematology, and immunology. BMS gains ex-China rights to select Hengrui assets while Hengrui advances several BMS immunology candidates in China. The model aims to shorten timelines to first-in-human data, influencing portfolio governance, manufacturing investment, and global regulatory sequencing.

Bristol Myers Squibb’s Hengrui agreement underscores how China-based early development may influence portfolio and manufacturing decisions.

BMS-Hengrui Pact Highlights China’s Rising Role in Drug Development

President Donald Trump has signed off on the dismissal of FDA Commissioner Marty Makary, according to sources close to the White House, cited by the Wall Street Journal.

 Makary has served as commissioner since March 2025. His expected departure adds to an alarming rate of senior official exits across federal health agencies that experts warn is eroding institutional continuity and long-term policy stability.

According to Reuters, a source close to the White House said the FDA commissioner "is done" and that Trump had signed off on the decision.

 The White House and the Department of Health and Human Services were not immediately available for comment.

Makary, a surgical oncologist at Johns Hopkins University School of Medicine, was confirmed as FDA commissioner back in March 2025.

 During his time at FDA, he’s become a prominent figure within the Make America Healthy Again (MAHA) movement backed by Health Secretary Robert F. Kennedy Jr. and authored bestselling books on healthcare costs and what he described as systemic failures in modern medicine.

During his tenure he championed several controversial positions, including pushing for large placebo-controlled trials for 

 vaccines in lower-risk age groups and overseeing significant shifts in the agency's approach to drug approvals, 

Reports of Makary's potential exit have intensified over the past week and are tied to concerns about those controversial decisions.

 Some within the administration are said to be “uncomfortable” with the political fallout generated by his more provocative regulatory moves, particularly the scrutiny growing around FDA's direction in Congress and former agency officials.

What is the fallout of Makary’s firing?

Upon Makary’s departure, FDA would be left without a permanent commissioner at a moment when the agency is already operating with acting heads in charge of its top drug development departments, including 

The timing also raises practical concerns around FDA's ability to navigate high-stakes decisions on drug approvals, vaccine policy, and food safety without stable, confirmed leadership in place.

Senior officials have departed the CDC and other federal health bodies at an alarmaing rate in recent months, raising concerns among public health experts about institutional continuity at agencies responsible for drug safety, disease surveillance, and pandemic preparedness.

Critics are also warning that the repeated churn of leadership makes it harder for these agencies to retain experienced staff, maintain long-term policy commitments, and respond effectively to emerging health threats.

For now, the White House has yet to name a potential successor or confirm the report.

Whether Makary's replacement will continue the MAHA-aligned approach he helped advance, or chart a more conventional regulatory course, is likely to be closely watched.

Trump plans to fire FDA chief Makary, WSJ reports 

https://www.reuters.com/world/us/trump-planning-fire-fda-chief-makary-wsj-reports-2026-05-08/

https://www.fda.gov/about-fda/fda-organization/martin-makary

President Trump has reportedly approved the dismissal of FDA Commissioner Marty Makary, who has led the agency since March 2025. The move compounds escalating leadership instability across federal health agencies, heightening concerns about weakened institutional continuity and policy durability. Makary, a Johns Hopkins surgical oncologist aligned with the MAHA movement, drew scrutiny for controversial stances on Covid-19 vaccine trial expectations and shifts in drug, vaccine, and mifepristone regulatory posture. The FDA now faces potential leadership gaps amid consequential decisions spanning approvals, vaccines, and food safety.

Trump to fire FDA Commissioner Marty Makary amid controversy over vaccine and drug policy decisions, leaving the agency without confirmed leadership.

Trump Planning to Oust FDA Chief Marty Makary 

Dennis Cantellops is an independent GMP and data integrity consultant and a former consumer safety officer for the US Food and Drug Administration.

Standard Quality Control Certification Assurance Guarantee Internet Business Technology Concept | Image Credit: ©Sikov -stock.adobe.com

The World Health Organization (WHO) defines manufacturing instructions as a “Master Formula,” an approved master document that describes the complete manufacturing process for a specific product and batch size.

 Equivalent terminology is used globally across good manufacturing practice (GMP) frameworks, including guidance from the WHO, European Union (EU), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and Health Canada.

 Although terminology varies across regions and regulatory organizations, these documents serve the same fundamental purpose: to ensure that manufacturing activities are performed in a consistent, controlled, and reproducible manner. For the purposes of this article, the term 

 (MPCR), as defined in 21 Code of Federal Regulations (CFR) 211.186, is used.

An MPCR is required for each product and batch size and forms the basis for the execution of batch production and control records (BPCRs). A 

, as defined in WHO GMP guidance, is a defined quantity of material produced in a single process or series of processes such that it is expected to be homogeneous.

 commonly refers to intermediates or bulk products and 

 to finished packaged products, the terms are often used interchangeably within GMP frameworks.

The MPCR is intended to ensure uniformity from batch to batch by providing complete, accurate, and approved manufacturing instructions. During batch execution, the MPCR is reproduced as a BPCR, which documents the actual manufacturing activities, materials, equipment, in-process controls, and critical process parameters associated with a specific batch. Under US current good manufacturing practice (CGMP) requirements, 21 CFR 211.186 establishes expectations for MPCR content, while 21 CFR 211.188 requires accurate and complete reproduction of the approved MPCR during batch execution.

Regulatory inspections frequently identify deficiencies in MPCRs and executed BPCRs, including incomplete documentation, omission of critical process parameters, lack of standardization, legibility issues, and inadequate second-person verification. Such deficiencies may compromise data integrity, delay batch release, and increase compliance risk. Inspection observations also indicate that these issues are often associated with inadequate document design, insufficient governance controls, and inconsistent application of electronic tools used to generate MPCR templates.

MPCRs may be implemented using paper-based, hybrid, or fully electronic formats. Paper-based systems remain widely used but are more susceptible to transcription errors, legibility challenges, and extended review timelines. Hybrid systems combine electronic templates with paper execution and are commonly used in industry; however, they may introduce additional complexity in document control and data management. Fully electronic MPCR and BPCR systems, when implemented in compliance with electronic records and signatures requirements under 21 CFRPart 11,

 can reduce documentation errors and enhance data integrity. However, such systems may require greater upfront investment, more extensive validation, and formalized change management processes, resulting in increased implementation complexity and resource requirements.

Spreadsheet-based applications are frequently used to support MPCR development across all documentation formats. When properly designed, validated, and governed, spreadsheet-based systems can provide structured data entry, automated calculation capabilities, improved standardization, and flexibility to accommodate manufacturing and regulatory changes. Compared with database-driven systems, spreadsheet-based tools may enable more efficient implementation of lower-risk changes and require fewer resources. Nevertheless, appropriate validation, access controls, and change management procedures remain essential to maintain GMP compliance.

The development and maintenance of MPCRs are closely linked to process validation and life cycle management. Changes to materials, equipment, processes, facilities, or procedures may require revision of MPCR templates to ensure continued assurance of product identity, strength, quality, purity, and potency. Effective MPCR design and governance support compliance with CGMP requirements, facilitate efficient review by quality units (QUs), and enable consistent execution of validated manufacturing processes.

This article presents a risk-based approach to the development, execution, and life cycle management of MPCRs, with emphasis on alignment with US CGMP requirements and internationally harmonized pharmaceutical quality system guidance, including International Council for Harmonisation (ICH) Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH Q9 Quality Risk Management, and ICH Q10 Pharmaceutical Quality System.

 Particular focus is placed on MPCR design, governance, and change management practices that support accurate execution of BPCRs, enhance data integrity, and reduce compliance risk throughout the product life cycle. The US Food and Drug Administration (FDA) guidance on data integrity further emphasizes the importance of reliable, complete, and traceable manufacturing documentation.

Regulatory Framework and Risk-Based Evaluation of MPCR and BPCR Systems

Inspectional observations, regulatory requirements, and industry practices related to the development and execution of MPCRs and BPCRs were evaluated to assess alignment with CGMP requirements. The evaluation focused on the completeness, accuracy, control, and reproducibility of MPCR templates, consistent with MPCR requirements described in 21 CFR 211.186 and master production instructions described in ICH Q7 Section 6.4. The evaluation also examined the accurate and complete execution of BPCRs in accordance with batch production and control record requirements described in 21 CFR 211.188 and batch production record expectations described in ICH Q7 Section 6.5.

 Additional evaluation criteria included documentation and record retention requirements under 21 CFR 211.180 and QU responsibilities for production record review, investigation of discrepancies, and approval or rejection of records under 21 CFR 211.22 and 211.192.

FDA Laboratory Information Bulletins (LIBs) describing spreadsheet design, validation, and electronic record controls were also reviewed to evaluate spreadsheet governance and validation practices applicable to MPCR template development and life cycle management.

 These practices were evaluated within the regulatory framework established under 21 CFR Parts 210 and 211 for CGMP documentation requirements and 21 CFR Part 11 for electronic records and electronic signatures.

The assessment examined documentation control, data integrity safeguards, and the inclusion of critical manufacturing and control elements. These elements included document version control; identification of critical process parameters; yield calculations and theoretical yield ranges; environmental conditions, such as temperature and relative humidity, where applicable; storage conditions; documentation of deviations and investigations; second-person verification of critical process steps; and documentation of change history. Additional factors evaluated included record legibility, completeness, consistency of entries, and controls designed to prevent unauthorized modification, omission, or backdating of records, consistent with regulatory expectations for data integrity.

Documentation governance practices were also evaluated, including QU oversight of production record review and approval. The extent to which production records were reviewed for completeness, discrepancies, and compliance with established procedures was assessed in accordance with CGMP and pharmaceutical quality system requirements.

MPCR and BPCR systems were further evaluated across different implementation formats, including paper-based, hybrid (paper and electronic), and fully electronic systems. The assessment considered the ability of each format to support document control, traceability, data integrity, and life cycle change management. Spreadsheet-based tools and database-driven systems were evaluated as representative electronic documentation approaches, including considerations for validation, version control, access control, audit trail functionality, and implementation of electronic records and electronic signature controls under 21 CFR Part 11.

Spreadsheet Governance Policies and Template Standardization for MPCR Development

Inspectional observations identified variability and incomplete reproduction of MPCR templates during BPCR execution, consistent with deficiencies in documentation controls required under 21 CFR 211.186 and 211.188.

 The absence of defined software governance policies and standardized template controls contributed to documentation inconsistencies, transcription errors, and increased QU review burden.

Implementation of standardized spreadsheet governance policies improved MPCR template standardization, reproducibility, and documentation accuracy. Spreadsheet templates provided structured data entry, controlled formatting, and automated calculation capabilities, which reduced manual transcription errors and improved documentation consistency. Spreadsheet governance and validation practices were evaluated in accordance with established spreadsheet validation principles and documentation controls described in FDA LIBs.

Spreadsheet validation and governance controls included defined template structure, protection of calculation cells, standardized formatting, controlled formula implementation, data validation rules, conditional formatting, and documented version control and change management procedures. When implemented as electronic systems, additional controls such as audit trails, electronic signatures, and access restrictions were evaluated in accordance with 21 CFR Part 11 requirements for electronic records and electronic signatures.

These governance practices improved documentation reliability, enhanced data integrity, and supported life cycle management of MPCR templates consistent with CGMP requirements and pharmaceutical quality system expectations.

Risk-based principles consistent with ICH Q9 were applied to evaluate the impact of documentation design and system controls on data integrity, operational consistency, and compliance risk.

 Life cycle management considerations consistent with ICH Q10 were also evaluated, including the ability of MPCR systems to support controlled change management, process updates, version control, and continued maintenance of validated manufacturing processes throughout the product life cycle.

These evaluation criteria provided a structured regulatory and risk-based framework for assessing MPCR and BPCR documentation systems throughout the pharmaceutical manufacturing life cycle.

Master production and control records (MPCRs) underpin reproducible manufacturing by defining approved instructions for each product and batch size and driving batch production and control records (BPCRs). Review of ~80 inspections found recurring gaps—missing critical parameters, yield calculations, environmental/storage conditions, deviation documentation, and second-person verification—often tied to weak document design and governance. Paper and hybrid records raise legibility and transcription risks; fully electronic systems improve traceability when validated to 21 CFR Part 11. Standardized, validated spreadsheet templates with controlled formulas and change control strengthen data integrity and QU review efficiency.

This article evaluates a structured, risk-based framework for the development, execution, and life cycle governance of master production and control records and batch production and control records systems aligned with current good manufacturing practice requirements and internationally harmonized pharmaceutical quality system guidance.

Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 1: Regulatory Framework, Inspectional Findings, and Documentation System Evaluation 

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