Quality Featured Articles

81. Six Serialization Mistakes Pharmaceutical Companies Make 12/21/2020

    This article examines mistakes that are commonly made in the planning and implementation phases of a serialization project and proposes a solution to avoid each of these issues.

82. Implementing Improved Analytical Methods To Support Vaccine Quality 12/18/2020

    Some of the new COVID-19-targeted vaccines are spurring the use of novel analytical technologies to support rapid and thorough characterization, which may help pave the way for other vaccine manufacturers to implement these technologies as well.

83. Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls & Best Practices 3/2/2020

    This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.

84. Experimental Methods For Microorganism Challenges On OWBA 2/17/2020

    While implementing online water bioburden analyzer (OWBA) technology might seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.

85. USP <1207> Updates Leak Testing Recommendations For Pharma Companies 10/2/2018

    Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.

86. 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.

87. Maintaining Data Integrity With Inspection Software 2/23/2018

    It may sound like just another pharma and life sciences industry buzzword, but “Data Integrity” is as important as computer system validation when products get released to market. 

88. The Role Of Packaging In Supply Chain Management 2/14/2018

    In order to achieve a successful supply chain management, packaging systems have to be connected with aspects of marketing, logistics, productions, and the environment.

89. Navigating The Marketing Authorization Process In Europe 2/6/2018

    To be able to market a medicinal product in Europe, you must obtain a Marketing Authorization (MA) from the relevant regulatory authority. There are a number of different routes to apply for an MA.

90. Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities 9/21/2017

    This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.