Articles From Our Expert Network
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How To Set Up An Effective Quality Risk Management Program
2/16/2022
The author of this article has taught courses on quality risk management (QRM) and its implementation as well as seen it in action in many companies. This article, Part 1 of a 2-part series, shares some of his observations and lessons learned in setting up an effective QRM program.
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Facilities Remediation, Renovation & Reconstruction: When Does It End?
2/7/2022
We sit at the beginning of 2022 amid the industry’s frantic and hurried effort to acquire, expand, and prepare more aseptic plant capacity — and to make it useable, compliant, and productive. This article provides a deep-dive on planning and design for your project, including walls, floors, ceilings, interstitial and mechanical spaces.
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Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon
1/10/2022
This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.
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The Data Integrity Body of Knowledge Expands with New & Pending Guidances
12/20/2021
Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.
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Using System Risk Structures To Evaluate COVID-19 Pandemic Risks
12/15/2021
This article's discussion demonstrates how system risk structures (SRS) can be used to understand complex risks and how SRS might be applied to understand the very complex risk landscape of the COVID-19 pandemic. It includes analysis of risk of personal infection, risk of disease progression or spreading, risk of vaccination, and more.
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Principles And Concepts Of System Risk Structures For Understanding & Managing Risks
12/6/2021
A truly effective risk analysis method for the biopharma industry should provide insights to and understanding of the fundamental properties and attributes that underlie every type of risk. This article describes how system risk structures (SRS) can be used to understand and manage both simple risk situations as well as complex risk landscapes quickly and efficiently.
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Calculating The Process Capabilities Of Cleaning Processes: A Primer
11/1/2021
The industry has begun the movement to science-, risk-, and statistics-based approaches to cleaning process development and validation. Process capability has become an important measure for demonstrating acceptable cleaning processe performance. Explore process capability, techniques used for its calculation, and how it's applied to cleaning processes.
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Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications
10/22/2021
While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.
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The Essential Components Of A Sterility Assurance Program
10/15/2021
The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.
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An Introduction To Biopharma Facility Design & Layout
10/11/2021
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.