Quality Systems

Jeffrey C. Mocny, PhD, is vice president of Regulatory Strategy at Abzena.

Anna McMahon is director of Regulatory Affairs at Cellares.

Articles

Jeffrey C. Mocny, PhD, of Abzena, and Anna McMahon, MS, of Cellares, discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.

Using Risk-Based Quality Frameworks to Fast-Track Biopharma Development: A Q&A with Abzena’s Jeffrey C. Mocny and Cellares’ Anna McMahon

Senior Program and Execution Leader
Independent

Documentation reliability across CDMOs, CROs, and other contractors should be engineered into quality systems before, during, and after execution, not patched together at submission or inspection time.

Documentation Reliability Across Contractors: A Quality Systems Approach

Michael Levy, MSc, MBA is senior vice president, Digital & Innovation, US Pharmacopeia (USP).

As quality control labs move toward more connected, data-driven operations, digital technologies must be adopted in a way that upholds patient safety.

Digital Standards Aim to Modernize Quality Assurance Without Compromising Confidence

Dennis Cantellops is an independent GMP and data integrity consultant and a former consumer safety officer for the US Food and Drug Administration.

This article evaluates a structured, risk-based framework for the development, execution, and life cycle governance of master production and control records and batch production and control records systems aligned with current good manufacturing practice requirements and internationally harmonized pharmaceutical quality system guidance.

Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 1: Regulatory Framework, Inspectional Findings, and Documentation System Evaluation 

Wilber Cruz is senior QC Microbiology manager at Abzena.

Wilbur Hightower is senior director, head of Site Quality at Abzena.

Vaishali Shah is previously head of Site Quality at Abzena.

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

Building a Future-Ready Contamination Control Strategy with Microbiology Testing

Malav Parikh is director, Quality Risk Management, Global Quality Compliance and Systems, Takeda.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about efforts in anticounterfeiting and the use of predictive modeling to validate transport conditions. 

Techniques for Securing the Supply Chain and Combating Counterfeit Medicines

Emily Null, MS, is a scientist with Steris Corp.

Mildred R. Bernardo is lead scientist with Steris Corp. 

Si Myra Tyson is a senior technical service associate for the Life Sciences Division of STERIS.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.

Identification and Remediation of Type III or Class III (Magnetite) Rouge in Manufacturing Equipment and Water Systems

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Gail Reed is senior scientist with Johnson & Johnson.

Yelena Ionova is senior manager, Data Strategy and Analytics with Redica Systems.

The authors detail a practical application of specification equivalence to excipients testing to achieve in-house harmonization.

Multi-Compendial Compliance for Pharmaceutical Excipients, Part 1: A Practical Application of Specification Equivalence

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Videos

Frank Romanski of Lonza Capsugel dives into the excipient side of manufacturing and the emerging prevalence of digitalization.

Regulatory, cGMP, and CDMO Challenges: A CPHI Conversation with Lonza Capsugel, Part Two

The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, and how manufacturers can incorporate process models into control strategies.

Quality Assurance/Quality Control