Featured Pharma Online Editorial

81. Are You Approaching LIMS Validation Correctly? 4/26/2021

    Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.

82. Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs 4/23/2021

    The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits. 

83. How to Ensure Your Quality Culture Assures Data Integrity 4/14/2021

    One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.

84. Rating Risk Events: Why Adjusted Risk Likelihood (ARL) Should Replace Risk Priority Number (RPN) 4/7/2021

    While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

85. Establishing An Effective Calibration Program 3/15/2021

    Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.

86. Applying QbD To Incorporate Excipients Into Drug Lifecycle Management 3/10/2021

    This article is the third in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation). In addition to life cycle management, the article delves into continued monitoring, multivariate analysis, continued product verification, and more.

87. Integrating Excipients Into QbD For Drug Development: Understanding Drift & Critical Material Attributes 3/3/2021

    This article is the second in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation). Learn about product, process, and excipient drift, as well as critical material attributes.

88. Incorporating Excipients Into QbD Studies For Drug Development — An Introduction 2/24/2021

    This article is the first in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the impact of excipient variability on finished product quality and more!

89. 7 Rules For Properly Interpreting Control Charts 2/15/2021

    It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. 

90. 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter 1/18/2021

    In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.