ARTICLES BY TIM SANDLE
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EMA Issues Paper On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety2/28/2025
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.
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5 Characteristics Of Forward-Thinking Microbiology Labs In 202512/6/2024
Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.
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Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients10/9/2024
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.
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EMA Issues New Draft Guideline: Chemistry Of Active Substances9/3/2024
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.
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Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations8/6/2024
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.
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ChatGPT-4: Practical Applications For The Biopharma Laboratory7/3/2024
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?
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EMA Updates Guidance On Inhalation And Nasal Product Quality5/29/2024
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.
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Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations5/6/2024
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.
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Getting Generic Drugs Right: FDA Revises ANDA Guidance2/14/2024
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.
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FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance1/25/2024
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.