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Ask the Expert: Proactive Measures to Address Drug Recalls

Preventing Pharmaceutical Product Recalls

In this episode of Ask the Expert, Susan J. Schniepp of Regulatory Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt of Parexel discuss common causes of pharmaceutical product recalls and strategies for prevention. Key drivers include microbial contamination, mislabeling, and physical contaminants such as glass particulates. Despite established quality systems, vulnerabilities involving subcontractors, production pressures, and human error can still lead to product quality failures.

 

The experts emphasize the importance of proactive quality oversight and effective investigation procedures. Microbial contamination requires a comprehensive contamination control strategy that integrates environmental monitoring, personnel monitoring, and water system data. Mislabeling risks can arise from seemingly minor process weaknesses, such as temporary handwritten labels and inadequate controls during product handling. Quality teams should actively engage with manufacturing operations to identify and address these vulnerabilities.

 

Preventing recalls requires more than documented procedures. Manufacturers should regularly test recall processes to ensure products can be traced and retrieved across complex global supply chains. By applying risk-based quality management principles, strengthening controls throughout manufacturing, and maintaining an integrated quality system, companies can improve oversight, reduce the risk of product quality failures, and better protect patient safety.

Watch the video: Preventing Pharmaceutical Product Recalls

 

Preventing Pharmaceutical Product Recalls

Ask the Expert: Working with Regulators to Develop Orphan Drugs

Navigating the Orphan Drug Development Pathway

In this episode of Ask the Expert, Susan J. Schniepp of Regulatory Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt of Parexel discuss regulatory considerations for medium-sized pharmaceutical companies pursuing orphan drug development. The experts explore the unique challenges of developing treatments for rare diseases, including regulatory engagement, clinical development, manufacturing, and commercialization.

 

Orphan drug designation offers incentives intended to support the development of treatments for small patient populations. These may include grants, tax credits, fee waivers, and additional regulatory support. However, orphan drugs must meet the same rigorous quality and compliance standards as traditional pharmaceutical products, requiring companies to establish effective quality systems and maintain regulatory readiness throughout development.

 

The experts also highlight operational challenges, including small-batch manufacturing, reliance on contract development and manufacturing organizations (CDMOs), global distribution, and patient recruitment for clinical trials. Companies with limited internal regulatory experience should consider seeking external expertise and maintaining close collaboration with regulatory authorities. Early planning and a flexible development strategy can help companies navigate these challenges while supporting the development of treatments for patients with rare diseases.

 

Watch the video: Navigating the Orphan Drug Development Pathway

 

Navigating the Orphan Drug Development Pathway

 

Ensuring the Supply Chain through Purchasing Controls

Building a Secure and Resilient Pharmaceutical Supply Chain

In this article, Jane Zhang, Co-Founder and Co-CEO of ETCH Sourcing, and Susan J. Schniepp of Regulatory Compliance Associates (RCA), a Nelson Labs company, discuss strategies for establishing a secure and reliable supply chain early in product development. The experts emphasize that supply chain vulnerabilities often originate during development when purchasing decisions are made without sufficient collaboration across development, quality, and procurement teams.

 

The article highlights the importance of cross-functional supplier management throughout the product lifecycle. Development teams should work with purchasing and quality to define supplier selection criteria, establish qualification and approval processes, implement quality agreements, and create ongoing supplier performance monitoring procedures. Clear accountability and communication among departments help ensure that supplier decisions address quality, regulatory compliance, reliability, and cost considerations.

 

The experts also emphasize the value of treating procurement as a strategic partner rather than a transactional function. Development teams define product requirements and performance needs, quality teams determine supplier acceptability, and purchasing teams identify reliable, qualified suppliers. By establishing documented procedures, clear responsibilities, and proactive supplier relationships early, organizations can build a more resilient supply chain and reduce the risk of costly disruptions as products advance toward commercialization.

 

Read the full article: Building a Secure and Resilient Pharmaceutical Supply Chain

 

Build a Supply Chain That Supports Quality From Day One

Secure supply chains don’t happen by accident they are designed early through strong purchasing controls, cross functional collaboration, and proactive supplier qualification. Regulatory Compliance Associates® works with pharmaceutical and medical device manufacturers to strengthen supplier oversight, purchasing procedures, and quality agreements that protect product integrity across the lifecycle.

 

If you’re developing a new product or reevaluating your supplier strategy, RCA can help you design a resilient, compliant supply chain from the start.

Connect with our experts: https://www.rcainc.com/contact-us/

Fundamentals of Batch Recovery Procedures

Pharmaceutical Batch Recovery Procedures

In this article, Susan J. Schniepp of Regulatory Compliance Associates (RCA), a Nelson Labs company, discusses best practices for recovering pharmaceutical manufacturing batches following production deviations. Batch recovery involves investigating and correcting identified issues to determine whether a batch can meet established quality, safety, and regulatory requirements. A thorough investigation, including root cause analysis and corrective and preventive actions (CAPAs), is essential to determining whether recovery is appropriate.

 

The article emphasizes the importance of a robust quality management system to support batch recovery decisions. Effective procedures should include risk assessments, comprehensive documentation, change control, trained personnel, data integrity controls, and collaboration between quality assurance and production teams. Timely investigations and clear communication are particularly important for time-sensitive products that may degrade while awaiting a recovery decision.

 

Schniepp also highlights that batch recovery is not appropriate in every situation. Decisions should be based on the severity of the deviation and whether the root cause has been conclusively identified and supported by documented evidence. Batches with multiple deviations should not be considered suitable for recovery. Ultimately, proactive quality management, thorough investigations, and continuous improvement can help prevent recurring issues while supporting product integrity and patient safety.

 

Read the full article: Pharmaceutical Batch Recovery Procedures

 

Article details

Pharmaceutical Technology®
Vol. 49, No. 9
Page: 26

 

Citation

When referring to this article, please cite it as Schniepp, S.J. Fundamentals of Batch Recovery Procedures. Pharmaceutical Technology 2025 49 (9).

 

Partner With Experts Who Strengthen Your Quality & Compliance Framework

Batch recovery decisions demand deep technical expertise, disciplined investigation practices, and a mature quality culture. Regulatory Compliance Associates® helps pharmaceutical manufacturers navigate complex deviations, strengthen root cause analysis, and build the robust quality systems needed to prevent issues before they occur.

 

If your team needs support with investigations, remediation, or elevating your overall quality and compliance maturity, RCA is here to help.

Learn more or connect with our experts today: https://www.rcainc.com/contact-us/

Audits, Inspections, and CDMOs

Preparing CDMOs and Sponsors for Regulatory Inspections

For contract development and manufacturing organizations (CDMOs), navigating regulatory inspections can become complex when multiple clients have different specifications, requirements, and expectations. While sponsors remain responsible for ensuring their contract organizations comply with applicable GMP requirements, effective inspection readiness requires close collaboration between both parties.

 

In this Ask the Expert discussion, Susan J. Schniepp and Anita Michael of Regulatory Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt of Parexel discuss how CDMOs and their clients can prepare for inspections and respond to regulatory actions.

 

The experts emphasize that inspection readiness should extend beyond preparing for an individual client inspection. CDMOs should maintain a robust quality system, supported by effective CAPA and investigation processes, deviation management, KPIs, and holistic tracking and trending. Facilities should also be prepared to demonstrate compliance across the six quality systems during GMP inspections, while understanding the specific expectations associated with pre-approval inspections.

 

By establishing strong quality systems and clearly defining responsibilities between CDMOs and sponsors, organizations can be better prepared to address regulatory inspections and respond effectively when issues arise.

 

Read the full article and watch the Ask the Expert discussion:

Audits, Inspections, and CDMOs

 

Link to the Video and Article on Pharmaceutical Technology

 

Strengthen your inspection readiness with a partner who understands the full regulatory landscape.

RCA supports pharmaceutical and medical device organizations with comprehensive audit preparation, supplier oversight, CDMO qualification, remediation planning, and ongoing quality system optimization. Whether you’re scaling operations or navigating complex regulatory expectations, our experts help you reduce risk and ensure confidence in every inspection.

 

Take the next step toward true compliance readiness.

Explore our full range of services here: Compliance Assurance Services or connect with our team to discuss your tailored compliance strategy today.

Ask the Expert: Commenting on Draft Regulations

In this episode of the Ask the Expert video series published by Pharmaceutical Technology®, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, Parexel, give their opinions on why those working in the pharmaceutical industry should lend their voices to draft regulations.

 

 

Regulatory agencies, such as FDA and the European Medicines Agencies, and other industry standard setting bodies, such as the International Council for Harmonisation and the US Pharmacopeia, often publish draft versions of the guidance documents they are developing to gather feedback from the public, which includes those scientists and engineers working in the pharmaceutical industry. But who should comment and why?

 

“You know, there’s an opportunity before regulations get approved for industry to participate and offer their comments on the regulation. This has worked in many cases where, for instance, in the US, way back in 2013, 2014, there was a proposal for metrics. And it was through the commenting period that was open to the public, where industry was able to put forth a case to get the agency to consider some other metrics that we thought were important, that they were not originally in the proposal,” explains Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates. “So, the way it works is anytime there’s a new regulation or a change to an already existing regulation, the FDA will announce it in what we call the Federal Register. It’s kind of like the daily newspaper for the government. It’s that time when they open it up for comments from industry. And so, it’s very important because you can change the final regulation before it becomes official by putting your comments in through this vehicle.”

 

“Absolutely anyone can comment,” stresses Siegfried Schmitt, PhD, is vice president, Technical at Parexel. “You don’t have to be the ultimate expert. If you feel you have something to say, absolutely, you can. Now, perhaps it is advisable or sensible to not just comment as an individual but perhaps comment through your company. Perhaps your company as such is interested in providing comments.”

 

Both Schmitt and Schniepp also suggest commenting through a trade association, such as the Parenteral Drug Association. “I like commenting through industry associations because usually, they gather a group of experts together proposed regulation topic, And you get to hear not only your perspective voiced, but other experts’ perspectives voiced,” Schniepp says.