Susan Haigney

Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging

In this episode of Ask the Expert, Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, addresses steps that can be taken to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection. A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences.

“This [investigation] should involve reviewing all processes related to production. That means aseptic filling, visual inspection, assembly and secondary packaging, of course, always including the relevant packaging components. And then second, define the right preventive action, if the investigation comes, for example, to the conclusion that the defective vials were already present after the filling,” says Margosch.

Click the video above to watch Dr. Margosch answer the following question:

“My company recently had critical incidental findings in several vials during secondary packaging. What can be done to minimize the risk of future market batches containing defective units?”

Dr. Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging, Vetter Pharma-Fertigung GmbH & Co KG

Dr. Dirk Margosch is Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter, a global CDMO specializing in aseptic filling and packaging of injection systems. Margosch holds a degree in food science. He joined Vetter more than 15 year ago and has held various positions in the field of visual inspection and packaging.

Dr. Margosch joined the pharmaceutical service provider Vetter Pharma-Fertigung GmbH & Co KG in 2008 as head of production overseeing process implementation, product-specific qualification and operation of automated visual inspection systems, until he was given the opportunity to manage the entire visual inspection department including both, manual and automated visual inspection. Since 2021, he has been responsible for non-aseptic production, which encompasses automated and manual visual inspection, assembly, and secondary packaging.

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

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

ACG, a supplier of integrated solutions for the pharmaceutical and nutraceutical markets, announced on Jan. 20, 2025 that it will be showcasing its line of sustainable packaging solutions at Pharmapack Europe, which is being held from Jan. 22–23, 2025 in Paris. ACG will be exhibiting at Stand E104, Hall 7.2.

During Pharmapack Europe, ACG will be highlighting their CelluPod paper-based, recyclable, and compostable blister system for products that require low water vapor transmission rates (WVTR). The company is also featuring its packaging solutions that are free of polyvinyl chloride (PVC). These include its PVC and Halogen-Free Thermoforming Blister System for products requiring low to medium WVTR. ACG also provides an eco-friendly alternative in its Bio D PVC. The company’s Halogen-Free Cold Form Blister System also provides a high-performance sustainable solution without halogen and PVC.

The company also announced its new head of Global Sales for ACG Packaging Materials, Jochen Scheil. With a background in mechanical engineering and more than 20 years of experience in large sales and service organizations in Europe, Asia Pacific, and the Middle East, Scheil previously held roles at Windmoeller & Hoelscher and Uhlmann Pac-Systeme.

"Joining ACG Packaging Materials at such a pivotal time is an incredible opportunity. I am thrilled to contribute to the company’s mission of driving innovative, sustainable packaging solutions globally,” said Scheil in the press release (1). With the launch of these products and our ongoing commitment to reducing emissions, ACG is setting a new standard for sustainability in the pharmaceutical industry."

"We’re delighted to welcome Jochen to the team. His leadership and vast experience in pharmaceutical packaging, combined with the efforts of his team in showcasing our sustainable products and processes, will play a crucial role in advancing our European expansion,” said Sheikh Akbar Ali, general manager, Development and Technology of ACG Packaging Materials, in the release.

At the Pharmapack event, ACG will also unveil its new state-of-the-art warehouse and slitting facility, which is located at its European site in Croatia.

 sat down Anil Andrade, vice-president of Global Sales at ACG World, during CPHI Milan to discuss growth in demand in the pharma industry and efforts put forth to achieve sustainable operations. In the interview, Andrade talked about the changing perceptions of the industry and the importance of sustainability in pharmaceutical operations. During the past 10 to 15 years, ACG has seen global growth in demand, and more so in Europe, North America, and Asia. Andrade also emphasized efforts to achieve sustainability to reduce the impact on the environment (2).

“Manufacturing capsules consumes a lot of water, and we have been trying to make our operations more efficient so that they consume less water, less paper, less plastic. In Croatia, as an example, we have reduced the paper consumption by almost 25 tons in a year. Same with plastic, we have reduced the consumption of plastic by 25 tons, and that has related to the benefits that we see going forward,” Andrade explained.

Listen to the full interview with Andrade at 

https://www.pharmtech.com/view/cphi-milan-2024-growth-and-sustainability-in-the-pharma-industry

ACG. ACG to Showcase Sustainable Packaging Innovations at Pharmapack Paris 2025. Press Release. Jan. 20, 2025.

Thomas, F. CPHI Milan 2024: Growth and Sustainability in the Pharma Industry. Oct. 18, 2024. https://www.pharmtech.com/view/cphi-milan-2024-growth-and-sustainability-in-the-pharma-industry

Articles

The company will be featuring its sustainable packaging solutions at the event in Paris on Jan. 22–23, 2025.

ACG to Showcase Sustainability Innovations at Pharmapack Europe 2025

Gerresheimer announced on Jan. 20, 2025 that it will be presenting its portfolio of containment, drug delivery, and digital solutions alongside Bormioli Pharma at Pharmapack 2025, which is being held from Jan. 22–23 in Paris, France. The two companies are exhibiting together following Gerresheimer’s acquisition of Bormioli, which was finalized in December 2024.

At the event, Gerresheimer will be featuring its primary packaging solutions and delivery systems for sensitive biologics, such as its EZ-fill Smart packaging platform for ready-to-fill (RTF) vials and cartridges. Gerresheimer’s Gx Elite syringes, cartridges, and vials offer protection for injectable drugs, especially novel biologics, says the company.

Also highlighted will be the company’s self-injectable devices, including the Gx Inbeneo auto-injector and the Gx SensAir on-body drug delivery device. “Both devices enable simple, patient-friendly application with high-precision dosing of the respective medication. The on-body drug delivery device can optionally be digitally connected and integrated into digital health platforms,” the company stated in a press release (1).

Gerresheimer will also provide a first look at their new digital solution for adherence support in clinical trials in the Innovation Gallery during a presentation by Sueyoung Yoon on January 23 at 11:40 a.m. “If medication is not taken as intended, this could affect data integrity, trial efficiency and the safety of trial participants. Gx Cap for Clinical Trials is a digitally connected tablet container cap, which enables the monitoring of oral medication intake so that trial participants can be reminded to take their medication if necessary. Gx Cap is already being used successfully by pharmacies in the US for remote therapeutic monitoring programs for certain therapeutic areas,” the company stated in the press release.

Experts from Gerresheimer will also be participating in presentations in the event’s Learning Lab and Sustainability Theater. Adrian Johnson will be giving a presentation, “Reducing the Carbon Footprint of our Products—Renewable Energy and Material Innovation as Viable Solutions” on January 22 at 12:55 p.m. in Sustainability Theater K85. Bernd Zeiss will be co-presenting, “A Partnership Worth More Than the Sum of Its Parts—Device Component Manufacturers Fulfil Syringe and System Performance Requirements”, in Learning Lab K3 on January 23 at 10:10 a.m., and Holger Krenz will be presenting “The innovation journey: Developing EZ-fill Smart as the New Industry Standard for Ready-to-Use Vials” on January 23 at 2:30 p.m. in Learning Lab K3.

Gerresheimer is a systems and solutions provider for the pharma, biotech, and cosmetic industries with a portfolio of drug containment solutions including closures and accessories and drug delivery systems. Their products include medication pumps, syringes, pens, auto-injectors, inhalers, vials, cartridges, ampoules, tablet containers, infusion, droppers, and syrup bottles. The company has more than 40 production sites in 16 countries in Europe, America, and Asia. Bormioli Pharma has a variety of pharmaceutical packaging solutions.

Gerresheimer and Bormioli Pharma can be found at booth F55 at Pharmapack in Paris Expo, Porte de Versailles from Jan. 22–23, 2025.

1. Gerresheimer. Two Stories–One Future. Gerresheimer and Bormioli Pharma at Pharmapack 2025. Press Release. Jan. 20, 2025.

The two companies will be exhibiting together after Gerresheimer’s December 2024 acquisition of Bormioli.

Gerresheimer and Bormioli Pharma to Showcase Containment Solutions at Pharmapack

Sustainability in Pharmaceutical Manufacturing

The pharmaceutical industry has been moving toward more environmentally friendly practices over the past decade. Regulators have also created sustainability requirements, especially in Europe.

“European regulations are particularly stringent on emissions and product lifecycle sustainability, and they have guided a lot of our initiatives such as a co-design, or carbon offset partnerships,” says Charles Ruban, president and CEO, Verdot.

Both small-molecule and large-molecule drug manufacturing have their own challenges, according to Ruban. Biopharmaceutical manufacturing is energy-intensive and creates material waste during production. Ruban says Verdot approaches the challenges of sustainable biopharmaceutical manufacturing by designing energy-efficient equipment that optimizes the use of material.

“We're partnering with suppliers committed to systemic sustainability, so our carbon-neutral initiative reflects the commitment of overcoming those models while enabling appliances to globally reduce their environmental footprint,” says Ruban.

Click the video above to watch the interview.

Pharmaceutical Technology® spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceutical manufacturing.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

The European Medicines Agency (EMA) announced on Jan. 10, 2025 that it is prepared for the implementation of the health technology assessment regulation (HTAR) that comes into effect on Jan. 12, 2025 (

) (1, 2). The HTAR accelerates and widens access to new medicines in the European Union and creates a framework for the assessment of certain high-risk medical devices. The allows for cooperation between regulators in the evaluation of the risks and benefits of medicines, expanding the cooperation between EMA and health technology assessment (HTA) bodies.

New regulations will start with new active substances for oncology products and advanced therapy medicinal products (ATMPs). Rules will then be expanded to orphan drug products in January 2028 and then all centrally authorized products in 2030.

The agency has been working with the European Commission (EC), EU Member States, and stakeholders from industry, healthcare, patients, and academia in preparation for its support of the regulation. EMA’s support of the HTAR will include helping to conduct timely joint clinical assessments (JCA) by the HTA Coordination Group (HTACG) by providing relevant information from its own regulatory assessments. The agency will also collaborate with the HTA Coordination Group in joint scientific consultations to provide scientific advice to technology developers and generate evidence to satisfy regulators and HTA bodies. EMA will also exchange information on upcoming applications and technologies for planning purposes.

"EMA welcomes the new HTA regulation and is ready to do what it takes to support the European Commission and the Member States in its successful implementation,” said EMA’s Executive Director, Emer Cooke, in the press release. “While our role is supportive, the new regulation will enable our collaboration across decision-makers reinforcing efforts to improve access to medicines for all patients in the EU. In our network strategy to 2028, facilitating the path to accessibility of new medicines for patients is a priority and the framework for cooperation and the exchange of information between regulators and HTA bodies provided by the new rules will help galvanize our efforts."

EMA has a legal obligation to notify the EC, which is the secretariat to the HTACG, and ensure that procedures are being followed and work is done is a timely and transparent way when marketing authorization applications are received that fall into the scope of JCA. HTACG estimates in 2025 it will need to conduct 17 JCAs for cancer drugs and eight JCAs for ATMPs. EMA also must provide information from ongoing regulatory assessments, details of which will be developed by EMA’s committee for human medicines and the JCA subgroup.

The first request period for JSC will be launched by the HTACG in February 2025, and developers can request parallel JSC with EMA.

“The future processes for parallel JSC have been built based on experience gathered since the initial piloting in 2008 and the iterations of process improvement performed over time. This year, the HTACG is planning to initiate five to seven joint scientific consultations for medicinal products and one to three joint scientific consultations for medical devices,” EMA stated in the press release.

EMA. New EU Rules for Health Technology Assessments Become Effective. Press Release. Jan. 10, 2025. 

https://www.ema.europa.eu/en/news/new-eu-rules-health-technology-assessments-become-effective

EU. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance), Dec. 15, 2021. EUR-Lex. 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

EMA Prepared for Health Technology Assessment Regulation Implementation

This story has been updated to include a comment by Glenn Wright, president and CEO of the Parenteral Drug Association.

An email communication, dated Jan. 10, 2025, released by FDA’s Center for Drug Evaluation and Research (CDER), announced the retirement of CDER Director, Patrizia Cavazzoni, effective January 18.

Cavazzoni joined FDA in 2018 as deputy director of operations in CDER and also served as acting principal deputy commissioner of Food and Drugs briefly in 2019. She was made director of CDER in 2021. Prior to working with FDA, Cavazzoni spent several years working in the pharmaceutical industry in the areas of clinical development, regulatory affairs, and safety risk management (1).

In a letter to her CDER colleagues announcing her retirement, Cavazzoni praised her team for how it handled the COVID-19 pandemic and the growth the center has shown in her years as director (2).

“While I could spend a lot of time enumerating our achievements, I want to highlight our biggest success: our people and our culture,” Cavazzoni said in the letter. “As I leave CDER, I can say with confidence that the Center is at its strongest. We have hired and retained record numbers of the best scientists and professionals. We have built a cohort of world-class managers and executives who are solidly at the helm of our organization and will continue to lead CDER. And most important of all, we created a culture that fosters respect for one another, inclusion, accountability, and diversity of thought and life experience. Our culture is what makes us strong and resilient, and it’s the foundation of what we have accomplished and will accomplish in the future.”

As of the time this article was written, FDA has not yet announced a replacement for Cavazzoni. Her predecessor, Janet Woodcock, was CDER director from 1994 to 2004 and then again from 2007 to 2021 (3).

®, Glenn Wright, president and CEO of the Parenteral Drug Association (PDA), said the following about Cavazzoni's retirement: 

“On behalf of PDA and our many industry members worldwide I thank Dr. Cavazzoni for her work as the CDER Center Director within FDA. Her efforts to move the industry and FDA forward to better serve patients is much appreciated. Communication between FDA and Industry is an essential part of ensuring expectations are well understood and concerns and issues raised. Her openness, and that of the Center she leads, to meet with Industry on topics of importance, speak at conferences and attend stakeholder meetings has been very helpful in this rapidly changing world.”

FDA. Patrizia Cavazzoni, M.D., Director–Center for Drug Evaluation and Research. FDA.gov. April 12, 2021. 

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/patrizia-cavazzoni

CDER Trade Press. CDER Director Patrizia Cavazzoni to Retire from FDA. Email Correspondence. Jan. 10, 2025.

FDA. Janet Woodcock, M.D. FDA.gov. Feb. 1, 2024. 

https://www.fda.gov/about-fda/fda-organization/janet-woodcock

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.