How Can We Help You?

When you partner with ValSource, you partner with leaders in risk management, process validation, and continued verification. We stand with you every step of the way.

ValSource Corporate Contact Information

  • 610.269.2808
  • 918A Horseshoe Pike,
    Downingtown, PA 19335
  • This field is for validation purposes and should be left unchanged.

Resource Center

Valid Insights

Forward Thinking: Read the latest in industry breakthroughs.

Recent Insights

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.

Full Article

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.

Full Article

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.

Full Article

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.

Full Article

CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance

By Ryan Murray, M.Sc., and Amanda McFarland, M.Sc., ValSource, Inc.

Read our recent publication with Outsourced Pharma — “CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance,” authored by ValSource team members Ryan Murray, Senior Consultant & Amanda Bishop McFarland.

Full Article

Risk Revolution Podcast: Risk Tolerance & Risk Acceptance with ValSource’s Jim Vesper

Welcome to Risk Revolution, a monthly series of Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.

This week, series coordinator Nuala is joined once again by Risk Revolution co-hosts, Valerie Mulholland and Lori Richter with another old friend of the IVT network, Dr. James Vesper (ValSource). Dr. Vesper will share his unique insights and deep learning on a very interesting aspect of RBDM, Risk Appetite, and the distinction between that and Risk Tolerance.

Listen Now

PDA Technical Report No. 88 – Microbial Data Deviation Investigations in the Pharmaceutical Industry

PDA Technical Report No. 88, written by ValSource’s Marc Glogovsky & Paula Peacos, along with other industry experts, presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the test, as opposed to providing methods for analysis of batch acceptability.

The distinct areas where microbial data is collected and inspected for deviation investigations are the focus of this document, including:

1) Roles and responsibilities of personnel, especially microbiologists, in the laboratory investigations and cross-functional teams responsible for manufacturing investigations,

2) Conducting laboratory investigations, and

3) Conducting manufacturing investigations.

The roles of other contributors to deviation investigations required for effective root cause analysis, such as representatives from manufacturing, process engineering, and quality assurance, are also briefly described.

This technical report promotes a lifecycle approach, but greater emphasis is placed on laboratory and manufacturing investigations of marketed drug products.

Full Technical Report available for download by February 13, 2022.

Click to Download

Training Production Operators In Aseptic Technique: Common Pitfalls & How to Avoid Them – Paula Peacos

Good, robust aseptic technique is critical to achieving successful contamination control during manufacture of aseptically processed products. Proper execution of aseptic technique is a skill that requires detailed, in-depth, targeted training, and demonstrated proficiency.

Read Article

Essential Points To Consider For Better Microbial Data Deviation Investigations – Paula Peacos

Microbial data deviation investigations (MDDIs) are notoriously difficult to perform. They are time-consuming and labor-intensive. For even the most experienced microbiologists, determining the definitive root cause is often challenging. In most cases, the microbiologist is investigating a past event — sometimes by as much as a week or two. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial and often scanty. Direct evidence (i.e., the “smoking gun”) is rare.

Read Article

Contamination Control Programs and the Microbiologist – The Changing Landscape – Paula Peacos & Marc Glogovsky, MS, S.M. (NRCM)

A contamination control program is like a puzzle. Each individual component, such as those mentioned above, represents a single piece of the puzzle. These pieces must fit together to form a whole in order to achieve the desired result.

Read Article

Quality Risk Management 101: ICH Q9 In Context – Kelly Waldron, Ph.D.

This is the third article in a series of six intended to provide a holistic primer on the field of quality risk management (QRM). The first article, Quality Risk Management 101: Risks Associated With Medicinal Products, discussed the difference between intrinsic and extrinsic risks and clarified the scope of QRM efforts and was followed by Quality Risk Management 101: A Brief History Of Risk Management In The Regulation Of Medicinal Products. Future articles will discuss the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.

Read Article

How To Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis – James Vesper, Ph.D., MPH and Amanda Bishop McFarland

When subject matter experts (SMEs), management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.

Read Article

Seeking the Golden Mean: Optimizing Your QRM Program – Amanda Bishop McFarland

If you were tasked with assessing your Quality Risk Management (QRM) program, would you find yourself in the “just right” category?

Read Article

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.

Read Article

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

Download E-Book

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.

Register Now

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.

Read Article

Articles & News

Press, updates, and more important information.

Articles & News

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.