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Resource Center

Publications & Industry News

Forward Thinking: Read the latest in industry breakthroughs.

Recent Insights

ISPE 3rd Edition of the Biopharmaceutical Manufacturing Facilities Baseline Guide

ValSource Business Unit Manager Kelly Waldron, PhD, was a lead author of the Quality Risk Management (QRM) Chapter in this publication.

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Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations

By ValSource Business Unit Manager Kelly Waldron, PhD; and Senior Consultant Patrick Mains; and Consultant Beth Fulton.

This article highlights some best practices for the use of risk registers in pharmaceutical manufacturing.

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Risk Tool Selection With ICH Q9(R1) In Mind

By ValSource Senior Consultants Amanda McFarland and Ryan Murray

This article published in Outsourced Pharma discusses ICH Q9R1 Quality Risk Management regarding the topic of formality and the role of uncertainty in risk tool selection.

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Assessing the Risk of a Clinically Significant Infection from a Microneedle Array Patch (MAP) Product

By Christine Craig, ValSource Consultant (co-author)

A recently published paper titled, “Assessing the risk of a clinically significant infection from a microneedle array patch (MAP) product,” co-authored by ValSource Consultant Christine Craig, identifies some of the key product and patient-specific factors that may contribute to the risk of infection from a MAP product and provides expert opinions in the context of guidance from regulatory authorities.

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A Risk-Based Approach for Managing Affinity Resin Contaminations

By ValSource Consultants Beth Fulton and Angelica Welch

A recent article by ValSource Consultants Beth Fulton and Angelica Welch published in the PDA Journal of Pharmaceutical Science and Technology outlines a risk-based approach for navigating remediation (non-routine sanitization) of contaminated affinity-based resins.

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A Four-Phased Approach for Evaluating a Quality Risk Management Activity

By ValSource Director of Learning James Vesper, PhD, MPH and Senior Consultant Amanda McFarland, MSC

A recent article by ValSource Director of Learning Solutions James Vesper and Senior Consultant Amanda McFarland published in Pharmaceutical Technology discusses how using the four-phased “Kirkpatrick Model” method in evaluating a QRM can ensure continual improvement and that regulatory requirements are met.

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ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity

By Danica Brown and Theo Zacharatos, ValSource Inc.

Check out part 2 of the ICH Q9(R1) article series from ValSource colleagues, Danica Brown and Theo Zacharatos. Get detailed insight on subjectivity and product availability risks.

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ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions

By Stacey Largent, M. Eng. and Virginia Andreotti-Jones, ValSource Inc.

The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

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How To Enable Your Quality Risk Management Lifecycle

By Tiffany Baker, Danica Brown, and Amanda McFarland; ValSource, Inc.

Dive into common risk management pain points and discover mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). Read our recent publication in Outsourced Pharma by ValSource team members: Tiffany Baker, Danica Brown, and Amanda McFarland.

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Parametric Release of Moist Heat Sterilized Products: History and Current State

By Michael J. Sadowski and Stephen E. Langille

Read our recent publication in the PDA – Parenteral Drug Association Journal of Pharmaceutical Science & Technology — “Parametric Release of Moist Heat Sterilized Products: History and Current State,” authored by Mike Sadowski, Lead Scientist, Sterility Assurance at Baxter Healthcare Corporation and Stephen Langille, Senior Microbiology Consultant at ValSource Inc.

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Annex 1 revision experts.

Our consultants are highly-recognized for their Annex 1 knowledge and expertise. We provide a plan forward through Annex 1 updates, today and into the future.