04/25/2022

"21 CFR 820’s New Terminology & Country-Specific Terms for Medical Device Quality"

Stephanie Gaulding, CQA, CPGP, Managing Director

Stephanie Gaulding, CQA, CPGP writes how the proposed revision to 21 CFR Part 820—including the trickle-down effects to 21 CFR Part 4—is a significant step toward global harmonization. The regulation reduces the amount of U.S.-specific regulation for medical device manufacturers, especially relating to structure and requirements for a medical device quality management system (QMS), and promotes consistency and clarity.

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03/25/2022

"A Method Validation Framework for Combination Products Part 2"

Adam Lambert, VP of Product and Process Development

Due to the complexity of combination products, drug sponsors may receive several deficiencies and compliance observations—known as 483 observations in the United States. Part two of Adam Lambert’s article clarifies important guidance points to help mitigate the risk surrounding validation of methods and to ensure a robust marketing application.

Read the article on Pharmtech’s website.

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03/25/2022

"A Method Validation Framework for Combination Products Part 1"

Adam Lambert, VP of Product and Process Development

Advancements in medical device and ancillary technologies are leading to significant improvements in the new combination therapies available to patients. Adam Lambert of Pharmatech Associates explains how the importance of getting buy-in from regulatory authorities early in the development process is critical to establish meaningful specifications.

Read the article on Pharmtech’s website.

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03/07/2022

"CMC and Quality Considerations When Engaging Your CDMO"

Bikash Chatterjee, Chief Executive Officer

Pharmatech’s Bikash Chatterjee discusses CMC and quality considerations when engaging your CDMO, in Life Science Leader’s annual CMO Leadership Awards 2022 issue.

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02/25/2022

"6 Tips to Ensure Your NDA/BLA Is Ready for FDA Review"

Michael Cooper, Clinical & Regulatory Affairs Program Manager

Pharmatech’s Mike Cooper explains that lapses are a common occurrence over a many-year product development life cycle, and gives us six points to consider to ensure your NDA / BLA is FDA-ready.

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02/09/2022

"ICH & USP Implementing A QbD Analytical Framework"

Brian Glass, Senior Analytical Consultant

In Outsourced Pharma, Pharmatech’s Brian Glass explains how new USP guidelines <1220> will affect CDMOs and drug sponsors. The quality by design (QbD) approach moves method development, qualification, and management away from an empirical framework to one that is based on scientific understanding — with methods that are well understood — as a product moves to commercial manufacturing.

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09/30/2021

"Decentralized Clinical Trials: Does Your Strategy Include These Facets?"

Michael Cooper, Clinical and Regulatory Affairs Program Manager

The FDA has long championed initiatives to make clinical trials more diverse, patient-friendly, and representative of the general population, based on healthcare as delivered in the real world. Pharmatech’s Michael Cooper writes about the ways regulatory and industry are moving toward real-world clinical trials leveraging technology available today.

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08/23/2021

"An Analysis of ICH Draft Guidance Q13 Continuous Manufacturing of Drug Substance and Drug Products"

Mark Mitchell, Principal Process Engineer

Mark Mitchell of Pharmatech, in BioProcess Online: “The ICH Q13 guideline adequately outlines the challenges and expectations of continuous manufacturing of drug substances and drug products. Most hurdles for implementation are not regulatory, but technological and procedural. Overcoming these hurdles lies with pharmaceutical manufacturers in establishing standard approaches for equipment design, control strategies, PAT instrumentation and validation, material diversion procedures, and RTRT. Proficiencies in these areas are applicable to both continuous and batch processing.”

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07/08/2021

"American Pharmaceutical Review: Controlled Release Roundtable"

Contribution by Adam Lambert, Ph.D., Vice President, Product and Process Development

Adam Lambert of Pharmatech Associates weighs in with fellow industry experts on how the COVID-19 public health crisis has affected the development of controlled release products and other industry trends, in the latest issue of American Pharmaceutical Review.

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06/07/2021

"Qualification Considerations for a “Factory-in-a-box”"

Moria Feighery-Ross, Sr. Validation Engineer, Wai Wong, VP Validation

The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. Enter the “factory-in-a-box,” which can be a game-changer for the industry. Where such modular factories are utilized, manufacturing capacity is limited only by the floor space to house them, which translates to reduced capital investment for scaling up and no lost time to construction.

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