Featured Articles

31. 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.

32. 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.

33. 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.

34. Environmental Monitoring Handbook For Pharmaceutical Manufacturers

    Acquire a thorough understanding of environmental monitoring, covering the fundamentals of particle counting and cleanroom designs, regulatory expectations regarding market release, and more.