Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
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12 April 2021 | By Charles River Laboratories
Join us on 1 June at 15:00 BST, as Jordi Iglesias visually summarise the ICH Q9 Quality risk management GMP document and explain how you can use the approach and tools described to proactively improve your microbiological QC assays in terms of data integrity.
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
Fact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
Whitepaper: Beta-glucans in purified water – do they really cause overestimation of endotoxin values?
Over the last century, the bacterial endotoxin test (BET) has evolved to keep pace with modern technology and lab expectations: from rabbit pyrogen testing to Limulus amebocyte lysate (LAL), to current developments with recombinant horseshoe crab coagulation factors.
Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.
Here are five ways to ensure a successful and compliant cleaning validation program.