Read, Learn, Innovate: Top Blog Posts from October 2021

Process validation (PV) aims at reassuring a manufacturer of constant product quality. Moreover, it is a regulatory requirement to achieve licensure of a pharmaceutical product Failing to efficiently plan and execute activities here leads to increased time-to-market. Statistics play a pivotal role here, as is shown by the fact that in the 22 pages of the latest FDA guidance document on process validation, statistical approaches and the need of statisticians in a multi-disciplinary team is mentioned no less but 15 times. This underscores the importance of showing statistical confidence about the chosen control strategy for critical process parameters (CPPs), input material, and measured CQAs during the manufacturing process.

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Pharmaceutical Engineering® magazine is proud to announce the 2020 Roger F. Sherwood Article of the Year is “Implementation of a Formal Energy-Efficient Design Process” (Mar-Apr) by Aoife Hamill, BE MSc, John Hanley, PhD, MPhil, CEng, and Vincent Lane.

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One of the most significant changes to the pharmaceutical industry in the last decade has been the increased speed in developing new therapies. A striking example of this is the rapid rollout of the COVID-19 vaccines. What usually took 10-15 years was researched, developed, and put into production in less than a year after scientists successfully revealed the virus's genetic code in January of 2020. New technologies and techniques are shortening the cycle time for other treatments and therapies.

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The ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry shows how KM can enhance nearly every element of the Pharmaceutical Quality System (PQS) across the product lifecycle and lead to other benefits such as improved business performance by increasing efficiency, building more robust processes, facilitating continual improvement, and creating an engaged knowledge workforce.

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Grand River Aseptic Manufacturing is the 2021 Facility of the Year Awards Winner for 2021 Special Recognition Award for Operational Agility: COVID-19 Impact for their Large-Scale-Fill-Finish Facility in Grand Rapids, MI.

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