Archives: Published Articles

Pharma Fundamentals: Biologics Development and PDA’s Technical Report No. 56

In this episode of PharmTech’s Pharma Fundamentals, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates and a member of PharmTech’s editorial advisory board, and Amnon Eylath, president and founder of Broad Spectrum GXP, discuss biologics development, the quality system, and the Parenteral Drug Association’s (PDA) revision to Technical Report No. 56 (TR56),1 which Eylath is a co-author on.

 

Link to the Video and Article on Pharmaceutical Technology

 

Applying Phase-Appropriate Quality Systems to Biologics Manufacturing

Developing biologics requires a quality system that accounts for the unique challenges of working with living cells, complex manufacturing processes, and contamination risks. The Parenteral Drug Association’s (PDA) Technical Report 56 (TR56), Application of Phase-Appropriate Quality Systems and Good Manufacturing Practice to the Development of Biological Product Drug Substance, provides guidance on scaling quality requirements throughout development.

 

This article explores how quality systems for biologics differ from those for small-molecule drugs, with particular emphasis on microbiological controls, containment, process sensitivity, and time-critical manufacturing decisions. Biologics often require more rigorous bioburden monitoring, environmental controls, and rapid, science-based investigations to address deviations before product quality is compromised.

 

The discussion also highlights the importance of container closure compatibility, extractables and leachables testing, risk assessment, and knowledge transfer throughout development and scale-up. While the underlying quality system framework is similar for both biologics and small molecules, biologics require specialized controls tailored to their unique characteristics.

 

By implementing phase-appropriate quality systems and addressing these challenges early, manufacturers can better manage development risks, maintain product quality, and support successful biologics manufacturing.

 

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Applying Phase-Appropriate Quality Systems to Biologics Manufacturing

Investigating Patient Complaints About Combination Products

In this audio clip originally published by by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

 

Link to the audio clip and article on Pharmaceutical Technology

 

Investigating Prefilled Syringe Complaints and Component Failures

When a patient reports that a prefilled syringe failed to inject, determining the root cause can be challenging, particularly when the drug manufacturer purchases the syringe from an external supplier. However, pharmaceutical manufacturers remain responsible for the quality and performance of their finished products, including the components used in their delivery systems.

 

In this Ask the Expert discussion, the expert explores how manufacturers can approach complaints involving commercial syringe components, emphasizing the importance of supplier qualification, quality assessments, and thorough complaint investigations.

 

The discussion also highlights the role of human factors and usability testing in ensuring that delivery systems are suitable for their intended patient populations. Manufacturers should evaluate whether patients can use the device correctly and whether existing instructions adequately address potential challenges.

 

Additionally, the article emphasizes the importance of reviewing complaint procedures, evaluating real-world feedback, and establishing clear responsibilities through supplier agreements and quality agreements. By strengthening supplier oversight, usability assessments, and complaint management processes, manufacturers can better address device-related complaints and support product quality and patient safety.

 

Read the full article and watch the Ask the Expert discussion:
Investigating Prefilled Syringe Complaints and Component Failures

Ask the Expert: Enhancing Out-of-Specification Procedures

This Video was published by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure.

 

Link to the Video and Article on Pharmaceutical Technology

 

Strengthening Out-of-Specification (OOS) Investigations and Procedures

Despite established regulatory guidance, pharmaceutical companies continue to receive inspection observations related to out-of-specification (OOS) procedures. In this Ask the Expert discussion, Susan J. Schniepp of Nelson Labs and Siegfried Schmitt, PhD, of Parexel explore common challenges in OOS investigations and how organizations can strengthen their processes.

 

The experts emphasize the importance of avoiding overly restrictive procedures that delay investigations and adopting a more comprehensive approach to identifying root causes. Key recommendations include implementing robust trending to identify recurring issues, evaluating the entire process from sampling through laboratory testing, and assessing potential sources of human error.

 

The discussion also highlights the importance of consistent OOS procedures across contract partners, comprehensive employee training, and electronic systems that provide timely access to relevant data. By focusing on process transparency, effective investigations, and meaningful performance indicators, pharmaceutical manufacturers can strengthen their OOS programs and improve inspection readiness.

 

Read the full article and watch the Ask the Expert discussion:
Strengthening Out-of-Specification (OOS) Investigations and Procedures

Navigating the QMSR Transition: Expert Insights on FDA Compliance, Risk Management, and Global Harmonization

Navigating the FDA’s Quality Management System Regulation (QMSR)

The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, aligns U.S. medical device quality system requirements more closely with ISO 13485:2016. However, the transition involves more than updating documentation and terminology. Manufacturers must address substantive changes to quality processes, risk management, and inspection readiness.

 

In this article, Jordan Elder, director of regulatory affairs at Regulatory Compliance Associates (RCA), a Nelson Labs company, discusses critical steps for transitioning from the Quality System Regulation (QSR) to the QMSR and maintaining compliance across global markets.

 

The discussion highlights the importance of conducting formal gap assessments, updating quality system documentation, strengthening risk management, and training personnel. Elder also addresses key areas requiring attention, including CAPA processes, management reviews, internal audits, complaint handling, supplier controls, and design documentation.

 

The article further explores how QMSR alignment with ISO 13485 can support global regulatory harmonization while emphasizing that additional requirements may still apply in markets such as the EU and Canada. Manufacturers should also ensure their inspection readiness practices reflect FDA’s updated QMSR inspection approach.

 

By addressing critical gaps and integrating risk-based quality management practices, medical device manufacturers can strengthen compliance and support access to international markets.

 

Read the full article:
Navigating the FDA’s Quality Management System Regulation (QMSR)

 

 

 

Designing a Test Plan that Works Globally: A Medtech Makers Q&A

Developing a Strategic Medical Device Testing Plan

A well-designed medical device testing plan is essential for demonstrating that a device is safe, effective, and performs as intended throughout its lifecycle. As discussed by experts from Nelson Labs and Regulatory Compliance Associates (RCA), an effective plan connects design requirements, risk management, applicable standards, and regulatory expectations to the testing needed to support market access. Testing may include biocompatibility, sterilization validation, packaging and shelf-life studies, functional performance, usability, and software verification.

 

Testing strategies should be tailored to the device’s intended use, materials, manufacturing processes, patient contact, and clinical application. For manufacturers pursuing global commercialization, identifying regional regulatory requirements early can help reduce redundant testing and support broader market access. While a single study may satisfy requirements across multiple regions, differences in regulatory expectations, documentation, and testing standards may require additional evidence.

 

The article also emphasizes the importance of early planning, scientifically justified sample sizes, and consideration of often-overlooked factors such as transportation conditions, environmental stability, aging, cybersecurity, and human factors. By engaging experienced testing and regulatory partners early, manufacturers can develop a risk-based strategy that generates the appropriate evidence while helping minimize delays, unnecessary costs, and potential redesigns.

 

Read the full article: Developing a Strategic Medical Device Testing Plan

 

Identifying Data Integrity Hotspots Using AI Technology

Data Integrity Hotspots

As artificial intelligence and digital twins become more integrated into pharmaceutical manufacturing and validation, they are creating new opportunities to improve efficiency, strengthen quality oversight, and accelerate decision making. In this second part of a two part interview, Susan Schniepp of Regulatory Compliance Associates discusses how these technologies can transform traditional manufacturing processes while maintaining an essential role for human expertise.

 

AI can serve as a centralized data aggregator, bringing information from multiple sources together to provide a comprehensive view of a manufacturing batch. By connecting process parameters, deviations, and other relevant information, the technology can help generate a batch dossier and accelerate the product release process. AI can also analyze large volumes of data to identify areas where data integrity risks may exist, allowing quality professionals to address potential vulnerabilities before they become actual compliance issues.

 

Schniepp emphasizes that these capabilities should complement rather than replace human decision making. A human in the loop remains essential for evaluating the information generated by AI and digital twins and making the final determination on whether a batch is suitable for release. This approach combines the speed and data processing capabilities of emerging technologies with the professional judgment and accountability required in a highly regulated pharmaceutical environment.

 

Read the full article: Digital Twins and the Future of Pharma Validation, Part 2