White Papers
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Viable And Non-Viable Environmental Monitoring To Meet USP 797
1/15/2021
The USP 797 requires sterility of all Compounded Sterile Products (CSP). Environmental Monitoring is an essential component to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications. Learn more about what viable and nonviable monitoring involves.
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EU GMP Annex 1 Insights
1/15/2021
The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.
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Classification, Qualification And Monitoring According To EU GMP Annex 1 Rev 12
1/15/2021
The goal of cleanroom monitoring is to assess the potential contamination risk of the product. The latest Annex 1 draft has some new definitions and guidance regarding cleanroom classification, qualification, and monitoring.
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Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations
1/14/2021
Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.
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Contamination Control Strategies For Pharmaceutical Manufacturing Environments
1/14/2021
Compressed gases, such as nitrogen, carbon dioxide, and oxygen, are used for a variety of applications in pharmaceutical manufacturing. To avoid sampling compressed gases, it has been speculated by some manufacturers that the rapid decompression of a gas when exiting its container kills any microbial contamination. However, it has been shown by multiple studies that microbial survival is not impacted by the typical compression or decompression seen in pharmaceutical process gases.
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An Introduction To Particle Technology In Pharmaceutical Manufacturing
1/14/2021
A basic understanding of particles and particle counting to help improve your cleanliness levels. In this beginner's guide to particle technology, you will learn about the physical nature, origins and behavior of particles.
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Improve Biopharma Fermentation With Innovation, Collaboration
12/28/2020
Many industry processes and parameters are still in the nascent stages of fermentation characteristic understanding, which is key to process development.
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The Evolving Role Of The GxP Archivist
12/16/2020
Customers and regulators expect the highest level of data integrity, and many organizations rely on an archivist to maintain and protect this most important asset. This white paper will assert that storing GLP data in the cloud is acceptable, provided certain conditions are met.
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Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records
12/7/2020
Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
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Why Biopharma Lifecycle Management?
12/4/2020
The biopharma industry has ambitions to accelerate industry 4.0.This white paper explores the major bottlenecks in the development lifecycle and the current barriers to effective digital transformation.