Featured Pharma Online Editorial

91. The Growing Value of Quality & Compliance Professionals in Decentralized Pharma 5/25/2022

    The phrase “the pharma ecosystem” has begun to pop up. Who is best suited to envision, support, and strategize a quality management vision in our current “ecosystem”? Here are some reasons your company and employees should value the unique skillset of these individuals more than ever.

92. Calculating Process Capability Of Cleaning Processes With Partially Censored Data 5/19/2022

    When cleaning sample results are below the detection limits (DLs) of an analytical method, these data are known as "non-detects" or "left-censored" data. There are basically two broad classes of methods that are applied to left-censored data: Substitution and Estimation. This article explores these methods for use with cleaning sample data when some of the points are below the DL.

93. Pharmaceutical Quality Compliance In 2022: Data Is Paramount 2/11/2022

    Pharma quality and compliance leaders must anticipate potential manufacturing issues before they happen by leveraging risk-based methodologies, continuously monitoring their systems, and tracking the profusion of data generated during the process. This article outlines the potential of data and analytics to improve quality performance.

94. 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.

95. 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.

96. FMEA Vs. System Risk Structures (SRS): Which Is More Useful? 9/24/2021

    In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?

97. Vaccine Manufacturing: Harnessing Lab Deviations 9/8/2021

    For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric content such as this from Tunnell Consulting's Bob Johnson. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

98. How To Find & Manage Biotech Consultants Effectively 9/6/2021

    The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

99. What's The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively? 9/3/2021

    When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

100. Best Practices To Ensure Quality Of Raw Materials Used To Manufacture Therapeutic Proteins 8/25/2021

     Across biologics, raw material quality is a key driver of product quality and consistency. This article recaps a recent U.S. Pharmacopeia (USP) workshop on the subject, including recaps of best practices and experiences shared by the FDA, Merck, Biogen, and more.