ARTICLES BY TIM SANDLE

• EMA Issues Paper On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety

  2/28/2025

  There has been limited guidance for assessing new or elevated impurity levels. To address this, the EMA has issued a "reflection paper" to consider what is needed for a safety evaluation and how to make assessments. The public comment period ends April 30.

• 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025

  12/6/2024

  Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.

• Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients

  10/9/2024

  In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.

• EMA Issues New Draft Guideline: Chemistry Of Active Substances

  9/3/2024

  The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

• ChatGPT-4: Practical Applications For The Biopharma Laboratory

  7/3/2024

  AI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver?

• EMA Updates Guidance On Inhalation And Nasal Product Quality

  5/29/2024

  The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.

• Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations

  5/6/2024

  Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

• Getting Generic Drugs Right: FDA Revises ANDA Guidance

  2/14/2024

  To improve the quality of abbreviated new drug applications (ANDAs) and to ensure improved consistency, the FDA has developed a new guidance to assist applicants in preparing and submitting amendments to tentatively approved ANDAs or in seeking final approval. This new guidance replaces the previous September 2020 version.

• WHO Guidance Seeks To Reduce Antimicrobials In Pharmaceutical Liquid Waste

  1/11/2024

  While most nations have regulations and emission standards regarding industrial waste containing antimicrobials, there is no globally accepted framework. This new WHO guidance seeks to establish an independent, scientifically derived framework for applying targets to manage discharges from antibiotic manufacturing facilities. The public comment period ends Jan. 26, 2024.
• Designing Facility Monitoring Systems For Cleanrooms

  12/4/2023

  Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.