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.

• Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations

  8/6/2024

  ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.

• 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.

• FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance

  1/25/2024

  The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024.