Featured Articles

  1. 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.

  2. Contamination Control Strategies For Pharmaceutical Manufacturing Environments 1/14/2021

    Many GMP standards recommend sampling process gases for contamination before use in critical manufacturing areas. Read on to learn about relevant regulatory requirements, microbial survival, and more.

  3. 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.

  4. 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.