Risk Management Featured Articles
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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.
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Materials Characterization In Pharma
9/5/2018
Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.
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Fast-Tracking A QbD Approach
12/28/2017
QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed.
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Viral Safety Approaches For Advanced Therapy Medicinal Products
7/11/2017
Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”
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Porosity And Its Influence On Pharmaceutical Tablet Dissolution Profiles
4/21/2017
Porosity is a good prediction of how liquids enter into the tablet matrix, and the expectations can be validated by experiment. Dissolution rates do not exclusively depend upon porosity; other predictors are also valid including solubility, surface area, and particle size. In addition to carrying out dissolution testing, establishing porosity, surface area and other characteristics are key to establishing the optimal dissolution rate.
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The Utility Of Specific Surface Area Measurement For Pharmaceutical Materials
4/20/2017
In the pharmaceutical world, particle size analysis has traditionally been the method of choice to “characterize” raw materials.
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Physical Properties Tests For The Pharmaceutical Engineer
2/23/2017
Products packaged for consumer use by the pharma industry go through a battery of tests related to how the user applies the product.
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The Impact Of Waste On The Cost Of Quality In The Pharma Industry
6/22/2016
Waste has a significant impact on the cost of quality (COQ) — or more exactly, the cost of poor quality — in the pharmaceutical industry.
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How To Increase Regulatory Flexibility And Tablet Production Efficiency
8/5/2015
The goal of every pharmaceutical developer is to create quality products that generate consumer satisfaction, require low cost, and have low risk.
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Managing QbD From A CMO Perspective
7/29/2015
The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality and reliability of their finished products, are gaining traction in pharmaceutical manufacturing. QbD enables pharmaceutical and biotechnology companies to identify, analyze, and control the sources of variation in manufacturing processes that can lessen the quality of drugs and other therapeutic products.