Featured Pharma Online Editorial
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System Risk Structures: A New Framework For Avoiding Disaster By Managing Risks
7/13/2020
Risks are ubiquitous, occurring in every aspect of our personal and professional lives. This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts.
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How To Drive Powerful CAPAs With Lean Six Sigma
7/10/2020
Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.
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Nitrosamine Impurities In Medicines: What Have We Learned?
7/8/2020
This article discusses the new EMA report "Lessons Learnt from Presence of N-nitrosamine Impurities in Sartan Medicines," sharing recommendations and the path forward suggested by the European regulators, as well as lessons learned from the GMP sampling, testing, and inspection processes.
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Introduction To The ASTM E3219 Standard Guide For Derivation Of Health Based Exposure Limits (HBELs)
7/1/2020
The procedures outlined in the newly published HBEL standard are expected to greatly aid professionals in the derivation of acceptable levels of carryover and should be used in the risk assessment of cleaning processes using the ASTM E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation.
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A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided
6/15/2020
Some leaders in the pharma, biopharma, and med device industries believe hiring consultants is quicker and more efficient than hiring a full-time employee. Does this thinking fail to factor in the investment required for thorough recruiting and training to ensure a successful engagement?
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What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks
6/12/2020
This article describes how the basic principles of managing personal risks of being infected by a respiratory virus can be used to manage risks for developing and manufacturing pharmaceuticals. The goal is to elucidate the basic principles of understanding, managing, and communicating a wide variety of risks from the trivially simple to the very complex.
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Introduction To The ASTM E3106 “Standard Guide To Science-Based And Risk-Based Cleaning Process Development and Validation”
6/5/2020
The new ASTM E3106 focuses much more attention on applying science and risk at the risk identification and risk analysis stages, including cleaning process development, than has been done in the past.
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Are You Ready? FDA’s Transition From Computer System Validation To Computer Software Assurance
6/3/2020
The FDA is preparing to release new guidance, "Computer Software Assurance for Manufacturing, Operations and Quality Systems Software," in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.
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Knowledge Management — Opportunities & Challenges For Legacy Drug Products
6/1/2020
This article will explore specific challenges of managing knowledge in a legacy manufacturing environment and propose viable, practical solutions that have been found to be effective. These solutions allow practitioners to increase product and process understanding as well as performance.
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2 (Major) Impediments To Faster Biopharma Product Development
5/29/2020
As pharma products have become more complicated, companies have become bogged down in accomplishing their mission of launching new products because of complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to patients.