Featured Pharma Online Editorial
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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!
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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.
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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.
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Using Production And Postmarket Data To Validate FMEA Assumptions
1/15/2021
One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.
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An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report
1/11/2021
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019.
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Seeing Double: Using Digital Twins To Improve Pharma Processes
12/30/2020
The pairing of the virtual and physical worlds not only enables systems to be adapted or repaired from afar, but the approach also further enables the analysis of data and monitoring of systems to avoid problems before they even occur.
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Tips For Building A Voluntary QA Culture In A 2021 COVID World
12/21/2020
As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.
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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.
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FDA FY2020 Drug Inspection Observations And Trends
12/9/2020
This article presents the FDA's most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years' worth of trends in drug GMP inspection enforcement.
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Managing CMO Quality And cGMP Compliance Capabilities: A Framework
11/25/2020
When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP.