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Publications & Industry News

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Recent Insights

Quality Risk Management And The Draft Annex 1 Revision — What To Expect – Hal Baseman and Kelly Waldron, Ph.D.

Part of the ValID Insight series, a timely look at issues and insights shaping the regulated pharmaceutical industry worldwide.

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ValSource Announces Three New Directors

DOWNINGTOWN, Pa. (Nov. 16, 2020) — ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today announced the addition of three new directors to the corporate board. The new ValSource directors include Diane Blumenthal, Katherine Oates, and Robert Radie, each bringing a diverse skill set to the leadership team.

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Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration

Dr. Kelly Waldron, a Senior Consultant at ValSource, served as lead author of the recently-published PDA/Biophorum Points to Consider entitled Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration. She led a team of experts in sterilizing grade filter manufacture and use through an intensive Quality Risk Management (QRM) exercise designed to enable a complete understanding of potential failures and related causal factors associated with the manufacture of sterilizing grade filters and their use by parental drug manufacturers. The risk assessment outcomes were used to create a sterilizing filtration control strategy aimed at patient protection.

The Points to Consider enables readers to perform a similar assessment using a number of QRM techniques at their own firms, which can improve sterility assurance and enable decisions regarding the inclusion or potential exclusion of commonly debated controls, such as pre-use post-sterilization filter integrity testing (PUPSIT). Dr. Waldron’s team was comprised of experts from over 25 companies, including both filter manufacturers and sterile drug producers, as of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. The Points to Consider document is available through PDA at the link below

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Points to Consider When Doing an Annex 1 Self-Assessment – By Darius Pillsbury and Stephen Langille. December 8, 2020 | 10:30 AM – 12:30 PM | EST

ValSource senior consultants Darius Pillsbury and Stephen Langille will deliver a 2-hour live training event through Pharma Webinars to discuss this important document.

Led by two experts, this inclusive live webinar will provide attendees with an overview of the history and changes to Annex 1, cover many of the topics necessary to ensure readiness for Annex 1 compliance, and describe the impact of this document on the global regulatory environment. Among the specific topics to be discussed during the webinar will be the development and implementation of a contamination control strategy, risk assessments and quality risk management for sterile products, control of cleanrooms and environmental monitoring, sterile filtration and filter validation, control and use of isolators and RABS for aseptic processing, personnel qualification and behavior in aseptic environments, and aseptic processing simulation requirements.

Following this webinar, attendees will understand the major points of emphasis in Annex 1 with regard to the control of sterile product operations and be able to complete a basic self-assessment to gauge their preparedness for Annex 1 compliance.

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Environmental Monitoring and Sterility Assurance Control for Medical Devices and Combination Products

In this article for Pharmaceutical Online, ValSource Principal Consultants Melissa Stappen and Stephen Langille discuss the amount of environmental control, environmental monitoring, and finished product testing necessary to ensure medicinal product microbiological safety and product quality.

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Stephen Langille elected to US Pharmacopeia’s Compounding Expert Committee

Senior Microbiology Consultant Stephen Langille was recently elected to the United States Pharmacopeia’s Compounding Expert Committee for the 2020-2025 cycle. (USP). The role of this Expert Committee is to develop new and revise existing general chapters related to physical analysis (e.g., particles, powders, rheology).

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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.