Contamination is a serious issue in cleanroom operations, and controlling contamination generated by human operators and their clothing is a major concern. People disperse large numbers of particles that vary in number from person to person and over time. Thus, cleanroom garments must be designed to protect the environment and the process by containing the particles generated by the person while not becoming a source of contamination. An important decision that faces the manager of any cleanroom is the selection of a cleanroom garment or garment system, according to Anne Marie Dixon-Heathman, principal, Cleanroom Management Associates. Following up on a presentation given by Dixon-Heathman at INTERPHEX 2021 on in-use testing of garments, 

 spoke to Dixon-Heathman for further insight. 

BioPharm International’s March 2022 Quality and Regulatory Sourcebook eBook.

Feliza Mirasol is the science editor for 

, March 2022
March 2022
Pages: 10–11, 29

When referring to this article, please cite it as F. Mirasol, “In-Use Testing of Cleanroom Garments," 

Articles

Quality

Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.

In-Use Testing of Cleanroom Garments

Throughout a single project, contract development and manufacturing organizations (CDMOs) generate an abundance of essential data that require an array of computerized systems to manage. These systems provide many benefits, including reducing human error, making processes more efficient, and enhancing security. More importantly, these systems can be used to help implement technical controls for data integrity (DI).

The importance of ensuring DI, particularly when data are used in decision-making for the regulated good practice (GxP) processes, is highlighted by the consistent updating of regulations first mandated by FDA in the early 1960s. Since that time, FDA and other regulatory agencies have continued to publish guidance emphasizing the need to maintain DI controls.

Before any new technology implementation, CDMOs need to fully understand the system as well as establish its intended use and perform risk mitigation to ensure robust DI controls. However, understanding and implementing the requirements of regulations surrounding computerized systems continues to be a challenge to many CDMOs today. Technology is not the predominant challenge to achieving regulatory compliance, but the lack of critical thinking skills when designing a quality system.

Calvin Kim is the senior director, head of IT quality systems and validation, for Samsung Biologics.

When referring to this article, please cite it as C. Kim, "How a Lack of Critical Thinking is Hindering Regulatory Compliance," 

Outsourcing

Why critical thinking must be applied before technology to ensure regulatory compliance.

How a Lack of Critical Thinking is Hindering Regulatory Compliance

Computer system validation (CSV), also known as software validation, is required by regulatory agencies throughout the development timeline. BioPharm International reached out to various experts associated with the FDA-Industry Computer Software Assurance (FISCA) team to discuss computer validation and add context to the ongoing discussion surrounding its use and importance in the greater regulatory landscape.

BioPharm International’s March 2022 Quality and Regulatory Sourcebook

Grant Playter is the Assistant Editor for 

When referring to this article, please cite it as G. Playter, “Contextualizing Computer Validation," 

Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.

Contextualizing Computer Validation

With the growth of chimeric antigen receptor (CAR)-T cell therapies comes the realization across the industry that CAR-T cell therapy development is a complex process requiring standardization, regulation, and meticulous quality control to generate safe and effective therapies. In addition, when developing CAR-T cells, biomanufacturers can have their choice of cell sources and bioprocesses, which can lead to variability in success as well as openings for inefficiency and waste. Analytical tools such as droplet digital polymerase chain reaction (ddPCR), a technology platform used to quantify nucleic acids, can support CAR-T cell manufacturers in developing successful CAR-T cell products. 

Mark White, PhD, is the associate director of Biopharma Product Marketing, and Marwan Alsarraj is the Biopharma Segment manager; both are at Bio-Rad.

When referring to this article, please cite it as M. White and M. Alsarraj, “Assessing the Quality of CAR-T Cells Using ddPCR," 

Analytics

CAR-T cell therapy development is a complex process that requires standardization.

Assessing the Quality of CAR-T Cells Using ddPCR

As the world becomes increasingly data-driven and the need for standardization and transparency between the various sectors of the bio/pharma industry heightens, Europe’s implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) continues to progress apace under the European Medicines Agency’s (EMA’s) substance, product, organization, and referential (SPOR) programme (1). To learn more about the ISO IDMP and the way that data and documents will need to be addressed in the future for bio/pharma companies, 

spoke with James Kelleher, CEO of Generis; and Frits Stulp, managing director, and Remco Munnik, associate director, both of Iperion Life Sciences, a Deloitte company.

BioPharm International’s March 2022 Regulatory Sourcebook eBook.

Felicity Thomas is the European editor for 

When referring to this article, please cite it as F. Thomas, “The Data Relationship,” 

BioPharm International's Regulatory Sourcebook 

Quality/Regulations

As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.

The Data Relationship

Disruptions in the bio/pharmaceutical supply chain that impact capacity and capabilities result in longer lead times for drug products, according to Ari Ojinaka, production manager at Astrea Bioseparations. The past two years of the COVID-19 pandemic have highlighted the importance of a healthy supply chain. “Through the pandemic, we have witnessed a significant reduction in inter-country transportation of goods and services and in-country COVID-19 restriction impacting capacity and capabilities to manufacture,” says Ojinaka.

 spoke with Ojinaka as well as Steve Kirk, vice-president Global Procurement, Catalent; Vincent Colicchio, vice-president, Supply Chain and External Manufacturing, Dr. Reddy’s Laboratories; and Hamilton Lenox, senior vice president–Business Development & Operations at LGM Pharma about the impact of COVID-19 on the supply chain and what companies can do to ensure the quality of their products.

Susan Haigney is managing editor of BioPharm International.

When referring to this article, please cite it as S. Haigney, “Supply Chain Considerations for Ensuring Quality," 

Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.

Supply Chain Considerations for Ensuring Quality

The 2023 final deadline for full US FDA Drug Supply Chain Security Act (DSCSA) unit level interoperable traceability is looming. By now, most pharmaceutical manufacturers are properly barcoding products to meet current DSCSA-specified labeling requirements for unique product identification at the lot level. The barcodes contain digitized product data that will be used to improve patient safety by enabling major improvements in the track-and-traceability of drugs as they move through the supply chain.

Now it’s time for companies to begin exchanging the necessary data to ensure readiness for November 2023. Establishing interoperability between all stakeholders up and down the supply chain is a complex undertaking—it will take every bit of time that remains before the deadline.

Tracy Nasarenko is senior director Community Engagement, GS1 US.

When referring to this article, please cite it as T. Nasarenko, “DSCSA's Next Big Hurdle," 

Interoperability by 2023 depends on data standardization and systems compatibility between trading partners.

DSCSA’s Next Big Hurdle

The logistics associated with the safe and efficient physical transportation of pharmaceuticals is increasingly taxing the minds of logisticians as medicines become more complex and labile and their regulatory oversight intensifies. The statutory need to maintain the therapeutic and physical integrity of drugs during transit renders the management of quality and the adherence to good distribution practice (GDP) guidelines an absolutely critical part of the pharmaceutical supply process.

Courtney Soulsby is sector director, Healthcare & Life Sciences, BSI.

When referring to this article, please cite it as C. Soulsby, A. Kennedy, “A New Route to Pharma GDP Compliance and Standardization," 

A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines. 


A New Route to Pharma GDP Compliance and Standardization 

In February 2020, travel ceased as the COVID-19 pandemic began to emerge. Since that time, we have come a long way with stay-at-home orders, social distancing, testing, tracing, and quarantine. Countries that implemented aggressive public health measures have had fewer cases and fewer deaths. The regulatory authorities also ceased to travel and were forced to utilize alternative mechanisms to assess industry compliance and review and approve new applications. This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

Until the time of the pandemic, the norm was that inspections would be performed as in-person on-site inspections. In the case of the European Union, Amended Directive 2001/83/EC, article 46(f) (1) explicitly states, “the holder of the manufacturing authorisation shall verify compliance by the manufacturer and distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites…” [emphasis added by author].

James Stumpff, RPh, is principal consultant at Parexel International. Siegfried Schmitt, PhD, is vice president Technical at Parexel International.

When referring to this article, please cite it as J. Stumpff, S. Schmitt, “Remote Inspections - Lessons Learned," 

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

BioPharm International, Regulatory Sourcebook March 2022