INSIGHTS ON QUALITY CONTROL

• A New Era Of Intuitive Simplicity In HPLC

  Explore a collection of use cases demonstrating the performance of an intuitively simple HPLC system, including common pharmaceutical QC applications, method migration from legacy systems, and more.

• A Comprehensive Solution For Critical Sample Analysis

  Discover how Germfree Laboratories overcame challenges for the Royal Canadian Mounted Police by designing a mobile lab with advanced biocontainment and state-of-the-art communication systems.

• ICH Q9 Revision 1: Enhancing Quality Risk Management

  ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.

• The Pain Of Change – Could Suppliers Be Part Of The Cure?

  Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.

• Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

  11/11/2024

  Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

• Water Activity And Primary Packaging For Oral Solid Dose Products

  7/10/2024

  The draft of the general chapter USP<922> 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.

• CMO Validation As A Service

  8/20/2024

  Learn about the highly successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility with the overarching goal of ensuring all equipment was qualified for a Phase 3 clinical production campaign.

• Leveraging A Modern HPLC System For Peptide Drug Substances Analysis

  8/22/2024

  This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.

• Aseptic Expertise And Delivery Of Services

  8/20/2024

  A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.