Insights On Quality Control

  1. Introduction To USP <922>: General Chapter For Water Activity Measurement 3/24/2022

    This article summarizes the importance of water activity and how laser-based headspace analysis can be used for water activity determination.

  2. Water Activity And Primary Packaging For Oral Solid Dose Products 2/17/2022

    The draft of the general chapter USP<922&GT says water activity determination can be used to assess the level of protection of primary packaging for an oral solid dosage product over its entire shelf life.

  3. Components Of An Effective Disinfectant Prequalification Strategy 1/24/2022

    Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.

  4. Rapid Microbial Detection Of Contaminants In Water Samples 4/7/2022

    Learn how rapid detection methods allow you to address contamination events sooner, avoid line shutdowns, release product to the market faster, and reduce warehousing costs.

  5. Making Sense Of Analytical Standards In Pharma QC 4/7/2022

    This webinar offers information on metrological traceability, the hierarchy of reference materials, certificates of analysis, reference material formats and uses, and fit-for-purpose selection considerations.

  6. Ensuring Container Closure Integrity Of A Gene Therapy Cancer Vaccine Needing Deep Cold Storage 7/22/2020

    A gene therapy clinical trial was halted due to CCI issues in deep cold storage. A CCI test method was developed that enabled non-destructive CCI testing of product vials at these cold temperatures. 

  7. Robotics & Automation On The Brink Of Transforming Pharma QC 4/1/2022

    In QC, there is still huge potential to accelerate the release of safe products. Here we review ways to boost the reliability, data integrity and productivity of microbiological testing.

  8. Proper Process Prevents Poor Lab Performance 4/21/2022

    In order for new technologies to improve lab efficiency, there must be a standardized way of understanding people, materials, processes and equipment.

  9. Considerations In Development & Manufacturing Of Complex Injectables For Early Phase Studies 2/7/2022

    A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.

  10. How To Understand ASTM E2500 12/21/2020

    ASTM E2500 introduced the term “verification” but was essentially silent on the idea of “commissioning” and the term “qualification.” ASTM is a minimum standard, and teams are free to go beyond this minimum as long as the basic provisions are met. There are four basic approaches in the industry currently.